Abstruse

Groundwork

To investigate the event of resistant starch (RS) on acute glycemic or insulinemic responses, the FDA indicates that control and RS-enriched foods must incorporate equivalent amounts of digestible carbohydrate. However, RS-containing foods typically incorporate less digestible carbohydrate per serving than control foods. Thus, controlling for digestible carbohydrate may yield dissimilar responses as compared with controlling for serving size.

Objective

The aim was to compare the postprandial metabolic responses to native wheat starch (NWS) versus RS type 4 (RS4) using digestible carbohydrate–matched portions compared with weight-matched portions.

Methods

A unmarried-blind, randomized-controlled crossover trial examined glycemic and insulinemic responses over 2 h post-obit consumption of 4 cracker conditions and a dextrose beverage in apparently healthy participants (northward= fourteen). Crackers provided 50 chiliad of digestible carbohydrate using the FDA'southward meal-intervention protocol or 35 g of carbohydrate by weight for the marketplace substitution method. Crackers differed only by the type of starch additive: NWS (MidsolTM 50; MGP Ingredient, Inc.) or RS4 (Fibersym® RW; MGP Ingredients, Inc.). Glucose concentrations were assessed at baseline and at 15, thirty, 45, 60, 90, and 120 min; insulin concentrations were measured at baseline and xxx, 60, and 120 min.

Results

In that location were no significant differences betwixt 50 g digestible carbohydrate cracker weather condition for glucose or insulin incremental AUC (iAUC). The 35 g carbohydrate past weight conditions were not different for glucose iAUC [hateful (95% CI): 35 g NWS: 1317 (677, 2169); 35 g RS4: 701 (262, 1351); P> 0.05]. However, insulin iAUC was lower following 35 g RS4 compared with 35 g NWS [35 1000 RS4: 92 (i, 259); 35 one thousand NWS: 697 (397, 1080); P< 0.01].

Conclusions

In good for you adults, consumption of RS4 crackers decreased postprandial insulin responses compared with NWS crackers when using the marketplace substitution method compared with the FDA standard testing method, with like postprandial glucose responses. Comparisons of the FDA standard testing method and the marketplace substitution method should be investigated farther to elucidate differential physiological impacts on consumers.

Introduction

Low consumption of dietary cobweb, which is principally boxy carbohydrate, is associated with reduced insulin sensitivity and increased risk for type 2 diabetes (i). The consumption of dietary fiber has shown promising outcomes associated with the reduction of chance for metabolic disease, including improving metabolic response outcomes, promoting satiety, and for obesity prevention and treatment (ii). While numerous studies have shown the beneficial wellness outcomes associated with dietary cobweb consumption, national consumption remains at ∼50% of the recommended dietary intake (iii–5). Resistant starch (RS) blazon iv (RS4) has recently emerged as a fiber (6) and has shown beneficial wellness outcomes in the postprandial menses post-obit acute consumption when substituted for flour in food (vii–9, 10, 11–13). Nevertheless, there is limited evidence to evidence an result of RS4 on glycemic and insulinemic responses when the test and command foods are matched for digestible carbohydrate.

The FDA maintains 2 methods of acceptable protocols to exam a fiber ingredient for food-labeling purposes. The test ingredient should either be added on top of all ingredients or substituted in place of an ingredient, while matching for digestible carbohydrates between the test and command foods (14). In contrast to the FDA protocol, the marketplace substitution method simply replaces an ingredient with the fiber. Fiber-fortified foods in the marketplace are not formulated to match the digestible sugar of the original products; rather, the fiber ingredients supercede digestible carbohydrates. This typically reduces the total caloric and digestible sugar content of a product, while increasing the fiber content.

The FDA standard testing method frequently increases the total caloric content of a test nutrient or requires large amounts of that nutrient to be consumed during testing sessions. In comparing, using the marketplace substitution method tin decrease the total caloric content for a examination nutrient when digestible carbohydrates are not matched. These methods are important for the food industry, as whatever food that has shown a beneficial health outcome in accordance with FDA regulations tin can be labeled with a health claim (xv). These health claims are tightly regulated past the FDA as a single wellness claim on a food product has been shown to increase sales substantially (16). Therefore, it is important to compare FDA standard testing protocols with marketplace substitution methods when investigating metabolic responses to different food products to determine differences betwixt testing methods on health outcomes.

The chief aim of this study was to investigate the metabolic responses, specifically glucose and insulin incremental AUC (iAUC), following consumption of 50 g of digestible saccharide from native wheat starch (NWS) crackers (MidsolTM 50; MGP Ingredients, Inc.) and RS4 crackers (Fibersym® RW; MGP Ingredients, Inc.). The secondary aim of this report was to investigate the metabolic responses to both crackers using the FDA standard testing protocol, where both crackers were matched for digestible saccharide, every bit well every bit the marketplace exchange method where RS4 was substituted in place of digestible saccharide. The marketplace exchange method was investigated using 35 g of crackers on a last production weight basis, representing an amount that is typically consumed according to the FDA (17). We hypothesized that the Fibersym® RW cracker would elicit a reduced glucose and insulin response compared with the NWS crackers at both the 50-g digestible carbohydrate dose and the 35-g-by-weight condition.

Methods

Participants

14 plain healthy participants (ages 20–38 y) with no history of diagnosed health conditions completed this study. Participants completed a medical history questionnaire to determine eligibility in the study. Participants were excluded from participation if they had a baseline fasting claret glucose ≥100 mg/dL, consumed a diet high in dietary fiber (>fifty g/d), were current smokers or smoked inside the last 6 mo, were meaning or lactating, had an allergy to wheat or gluten, or had any diagnosed health conditions that may affect metabolism. Written and oral consent were obtained from all participants. This study was approved by the Institutional Review Board for Research Involving Homo Subjects at Kansas Country Academy (IRB #8740) and conformed to the Declaration of Helsinki.

Experimental design

This written report was conducted as a unmarried-blind, randomized-controlled crossover trial, where all participants underwent all testing conditions. Participants were randomly assigned to a series of 5 randomly ordered conditions, blocked in a Latin-foursquare pattern. The atmospheric condition were as follows: i) l g dextrose drink (50Dex; Trutol®fifty glucose-tolerance beverage; Thermo ScientificTM), 2) 50 g of digestible sugar from NWS crackers (50NWS), three) 50 one thousand of digestible carbohydrate from RS4 and NWS crackers (50RS4), 4) 35 g of NWS crackers by weight (35NWS), and 5) 35 thousand of RS4 crackers past weight (35RS4). Further details for the cracker atmospheric condition are outlined inTable 1. All testing sessions were performed at the Physical Action and Nutrition Clinical Research Consortium at Kansas State University, Manhattan, Kansas. All participants completed all five weather, each following a ten–12-h fast, with a minimum of 48 h between sessions. To ensure consistency in responses, participants were asked to maintain their typical dietary and physical activeness habits throughout the report. Additionally, participants were asked to write downwardly what they ate the nighttime prior to their first testing session and were reminded to consume this aforementioned meal prior to subsequent testing sessions. Inclusion criteria included the following: ane) plain healthy adults with no diagnosed health weather, two) nonsmokers, 3) not consuming a loftier- or low-fiber nutrition (>fifty k/d or <5 g/d), and four) lack of a wheat or gluten allergy. Participants who did not meet all inclusion criteria were excluded from participation. Participants who met the inclusion criteria at the first visit were enrolled in the study and later on completed pretrial assessments of peak, weight, and waist circumference, followed by an oral-glucose-tolerance test protocol. Next, participants completed a postprandial assessment for 1 of the 5 randomized conditions. The remaining 4 visits were performed using the postprandial assessment only. Satiety was measured via the Holt Satiety Questionnaire at baseline and at 30, 60, ninety, and 120 min during each testing session, while adding a DXA scan at the terminal testing session to mensurate torso composition.

Tabular array 1

Nutrient composition of each condition (per 100 g) 1

50NWS 50RS4 35NWS 35RS4
Ash, g 1.0 1.seven 0.v 0.7
Wet, g 3.4 four.2 1.7 ane.2
Carbohydrate, 1000 50.3 71.3 25.viii 26.1
 Digestible carbohydrate, g 50.0 fifty.0 25.6 v.one
 Dietary cobweb, 1000 0.three 21.3 0.ii 21.0
Fat, thousand seven.vi 10.8 3.9 four.0
Poly peptide, g 6.0 8.5 three.1 3.1
Total calories, kcal 292.0 331.iv 149.vi 69.5
Concluding production weights provided to participants, chiliad 68.3 35.0 RS4 + 61.iii NWS (96.3 total) 35.0 35.0
50NWS 50RS4 35NWS 35RS4
Ash, chiliad 1.0 1.7 0.5 0.7
Moisture, 1000 three.4 4.2 1.7 1.2
Saccharide, g 50.iii 71.iii 25.8 26.1
 Digestible sugar, g 50.0 50.0 25.half dozen 5.ane
 Dietary fiber, g 0.three 21.iii 0.2 21.0
Fatty, thou seven.6 ten.8 iii.9 four.0
Poly peptide, g vi.0 8.5 3.1 iii.i
Total calories, kcal 292.0 331.4 149.6 69.5
Final product weights provided to participants, g 68.three 35.0 RS4 + 61.3 NWS (96.3 total) 35.0 35.0

1Digestible carbohydrate was calculated as saccharide (1000) minus dietary cobweb (1000). NWS, native wheat starch; RS, resistant starch; 50NWS, 68.33 yard native wheat starch cracker (delivering l thousand digestible carbohydrate); 50RS4, 61.27 g resistant starch blazon 4 + native wheat starch crackers (delivering fifty g digestible carbohydrate). Marketplace substitution weather: 35NWS, 35 thousand native wheat starch cracker; 35RS4, 35 chiliad resistant starch type 4 cracker.

Tabular array one

Nutrient limerick of each condition (per 100 g) 1

50NWS 50RS4 35NWS 35RS4
Ash, g 1.0 1.7 0.5 0.7
Wet, g three.iv iv.2 ane.7 i.2
Saccharide, g fifty.iii 71.3 25.eight 26.i
 Digestible carbohydrate, g fifty.0 50.0 25.half-dozen 5.ane
 Dietary fiber, k 0.3 21.3 0.2 21.0
Fatty, thou 7.half-dozen ten.viii 3.nine 4.0
Protein, g six.0 8.5 3.1 3.1
Total calories, kcal 292.0 331.4 149.6 69.5
Last production weights provided to participants, one thousand 68.3 35.0 RS4 + 61.3 NWS (96.three total) 35.0 35.0
50NWS 50RS4 35NWS 35RS4
Ash, g i.0 1.vii 0.v 0.seven
Wet, g three.4 4.two 1.7 1.2
Saccharide, g l.three 71.3 25.8 26.1
 Digestible sugar, k 50.0 50.0 25.6 five.ane
 Dietary fiber, one thousand 0.three 21.three 0.two 21.0
Fat, thousand 7.6 ten.8 iii.9 iv.0
Poly peptide, k 6.0 8.five 3.i 3.i
Total calories, kcal 292.0 331.iv 149.vi 69.five
Last product weights provided to participants, grand 68.iii 35.0 RS4 + 61.3 NWS (96.3 full) 35.0 35.0

1Digestible carbohydrate was calculated as carbohydrate (g) minus dietary fiber (g). NWS, native wheat starch; RS, resistant starch; 50NWS, 68.33 g native wheat starch cracker (delivering 50 yard digestible carbohydrate); 50RS4, 61.27 thou resistant starch type 4 + native wheat starch crackers (delivering 50 g digestible carbohydrate). Marketplace substitution conditions: 35NWS, 35 g native wheat starch cracker; 35RS4, 35 grand resistant starch type 4 cracker.

Postprandial assessment protocol

Upon enrollment into the written report, and completion of pretrial measurements, at each session an indwelling catheter was inserted in the antecubital vein in the forearm by a researcher trained in phlebotomy. A 24-gauge safelet intravenous catheter (Exel International) was used to maintain an open up port throughout the ii-h testing session. A steady infusion of 0.9% NaCl was used to maintain catheter office and was fixed in place via Tegaderm film (3M Healthcare). A iii-mL syringe (BD), attached to a iii-manner stopcock (Fisher), was used to clear the intravenous line of saline prior to whole-blood collection. A five-mL syringe (BD) was then used to collect whole blood at each time point. Once the baseline blood sample was drawn, participants were instructed to consume their cracker condition or glucose tolerance beverage within a fifteen-min flow. The ii-h postprandial assessment started upon completion of the last swallow for every status to minimize the differences in consumption time and to add command to the starting time fourth dimension among all participants. Approximately 500 mL of water was provided at each session and was kept constant throughout the elapsing of the study.

Belittling procedures

To determine blood glucose, blood samples were taken at baseline and at 15, 30, 45, 60, ninety, and 120 min following consumption of the randomized condition. To determine insulin, samples were taken at baseline and at 30, 60, and 120 min. Whole-blood samples were drawn into a v-mL syringe (BD). A pocket-sized sample of whole blood was expelled from the 5-mL syringe and whole-blood glucose was measured using a Bayer Contour Glucose Monitoring System. Samples were measured in duplicate or until ii readings from the glucose monitoring system were within 5 units of understanding (milligrams per deciliter). The final value used for analysis was the mean of ii measurements that were within five units of agreement. Upon completion of the glucose measurement, the remaining whole claret was expelled into a 6-mL Vacutainer test tube coated with EDTA (BD). Blood samples were centrifuged at 1800 × grand at room temperature for 12 min. The plasma was and then pipetted into 3 aliquots in 0.half-dozen-mL microcentrifuge tubes (Fisher) and stored at −80°C until study completion (∼6 mo). Upon completion of information collection, ane aliquot of plasma was shipped to the Radioimmunoassay and Biomarkers Core of the Academy of Pennsylvania Diabetes Research Center to decide plasma insulin using double-antibody radioimmunoassay in duplicate (EMD Millipore, Billerica, MA). The insulin intra-analysis CV was 4.99% and inter-assay CV was xi.3%. The remaining two aliquots of plasma, intended for insulin analysis, were stored in case of shipment failure or in cases where analysis of samples yielded errors. Where catheter insertion was not possible, or upon failure of the intravenous line once inserted, blood glucose was nerveless via finger stick, whereas insulin was not nerveless. Among all instances where catheter insertion was not possible, participants refused additional catheter insertions primarily due to needle discomfort. Blood glucose was not used for data analysis in these situations, as it was determined that these methods were statistically different. Therefore, there were missing data for participants on days where catheter failure occurred.

Analytic parameters

Summit parameters (milligrams per deciliter) were defined equally the highest concentration of glucose or insulin observed during the ii-h testing session. Baseline-to-peak (milligrams per deciliter) was defined equally the difference betwixt the peak value and the baseline value the participant had at the get-go of the testing session. Time-to-peak (minutes) was defined as the amount of time it took for the participant to reach the peak value observed during the testing session.

The estimated ways and CIs from the models are reported in the text and iAUC, meridian, baseline-to-meridian, and fourth dimension-to-peak were analyzed for glucose and insulin. A final sample size of n= 13 was determined to exist sufficient to detect effects based on data from Al-Tamimi et al. (13). Estimated values were converted dorsum to the original units using the emmeans package in R (R Foundation for Statistical Computing), and raw data are graphed (Effigy 1) to help with interpretability.

Figure i

Postprandial glycemic and insulinemic responses to dextrose and all cracker conditions during the 2-h test period. Values are means ± SEs. (A) Glucose response (mg/dL). (B) Insulin response (μIU/mL). FDA standard testing conditions: 50Dex, 50 g dextrose; 50NWS, 68.33 g native wheat starch cracker (delivering 50 g digestible carbohydrate); 50RS4, 61.27 g resistant starch type 4 + native wheat starch crackers (delivering 50 g digestible carbohydrate). Marketplace substitution conditions: 35NWS, 35 g native wheat starch cracker; 35RS4, 35 g resistant starch type 4 cracker.

Postprandial glycemic and insulinemic responses to dextrose and all cracker conditions during the two-h examination period. Values are means ± SEs. (A) Glucose response (mg/dL). (B) Insulin response (μIU/mL). FDA standard testing conditions: 50Dex, 50 g dextrose; 50NWS, 68.33 g native wheat starch cracker (delivering l grand digestible sugar); 50RS4, 61.27 thousand resistant starch type 4 + native wheat starch crackers (delivering fifty g digestible carbohydrate). Marketplace exchange conditions: 35NWS, 35 thousand native wheat starch cracker; 35RS4, 35 g resistant starch type 4 cracker.

Effigy ane

Postprandial glycemic and insulinemic responses to dextrose and all cracker conditions during the 2-h test period. Values are means ± SEs. (A) Glucose response (mg/dL). (B) Insulin response (μIU/mL). FDA standard testing conditions: 50Dex, 50 g dextrose; 50NWS, 68.33 g native wheat starch cracker (delivering 50 g digestible carbohydrate); 50RS4, 61.27 g resistant starch type 4 + native wheat starch crackers (delivering 50 g digestible carbohydrate). Marketplace substitution conditions: 35NWS, 35 g native wheat starch cracker; 35RS4, 35 g resistant starch type 4 cracker.

Postprandial glycemic and insulinemic responses to dextrose and all cracker weather during the 2-h examination period. Values are means ± SEs. (A) Glucose response (mg/dL). (B) Insulin response (μIU/mL). FDA standard testing weather condition: 50Dex, 50 g dextrose; 50NWS, 68.33 g native wheat starch cracker (delivering 50 g digestible saccharide); 50RS4, 61.27 g resistant starch blazon four + native wheat starch crackers (delivering l thou digestible carbohydrate). Marketplace substitution atmospheric condition: 35NWS, 35 thousand native wheat starch cracker; 35RS4, 35 one thousand resistant starch type iv cracker.

Body-composition measures and questionnaires

Height, weight, and waist circumference measures were nerveless in duplicate and the hateful values were used for data assay. Pinnacle was measured to the nearest 0.i cm using a portable stadiometer (Invicta Plastics). Participants were measured with heels, buttocks, and shoulders touching the apartment upright surface. Weight was measured to the nearest 0.1 kg with an electronic scale (Pelstar LLC). Waist circumference was measured to the nearest 0.ane cm using a record measure by locating the acme of the iliac crest. Measurements were taken at the finish of the participant'southward normal exhalation. DXA was used to make up one's mind body composition (GE Prodigy; Lunar-General Electric). Participants were asked to take jewelry, shoes, and annihilation with metal off before lying in a supine position for ∼six–10 min for the DXA scan. Satiety was measured throughout each trial using the Holt Satiety Calibration. This 7-indicate visual analog scale has equally spaced options that include extremely hungry, hungry, semi-hungry, no particular feeling, semi-satisfied, satisfied, and extremely satisfied. The Holt Satiety Scale was previously used to determine the satiety index of common foods and used in this report to measure satiety to the cracker weather (18). The International Physical Action Questionnaire–Brusk Form (IPAQ-SF) was used to assess concrete activity levels for each participant. This questionnaire covers 4 domains of physical action, including work-related, transportation, household/gardening, and leisure-fourth dimension physical action. The questions include frequency factors, number of days per calendar week, and time conducting various activities including sitting, walking, and moderate- and vigorous-intensity physical activity. The main employ of the IPAQ-SF in this study was to determine whether physical activeness levels inverse during the study.

Dextrose drink and cracker details

The glucose-tolerance examination beverage provided l g of dextrose (catalog number 401074P; ThermoFischer Scientific). The crackers were produced locally at the American Found of Baking (Manhattan, KS). The four cracker conditions were fabricated using the same ingredients other than the type of starch. The RS4 cracker was fabricated by replacing NWS in a cracker with a blazon 4–resistant wheat starch, whereas the NWS cracker was made solely from NWS, all the while maintaining poly peptide content constant past adding wheat gluten. The 50NWS cracker status was tested using 68.33 g NWS providing l g of digestible sugar from NWS. The 50RS4 cracker condition was tested using a combination of 35 grand RS4 + 61.27 g NWS providing 50 m of digestible sugar. The 35NWS cracker was tested equally 35 chiliad of NWS cracker by final product weight, and 35RS4 was tested using 35 thou of RS4 cracker by final product weight. All ingredients were nutrient grade and mostly recognized every bit safe (GRAS). Both the NWS (MidsolTM 50) and RS (Fibersym® RW) were provided by MGP Ingredients, Inc. (Atchison, KS), with food-grade documentation (Table 1). Finished NWS and RS4 crackers were nearly identical and could only be distinguished by the label on their designated package.

Statistical analysis

Information analyses were conducted in R, version 3.five.3 (19). Repeated-measures mixed-effects regression models were conducted for each of the outcome variables to account for missing data. Chief outcomes were glucose iAUC and insulin iAUC. Secondary outcomes were glucose and insulin height, baseline-to-tiptop, and time-to-peak. Main effects of condition, dose, and condition × dose were included as stock-still effects in all primary and secondary analyses. Condition (NWS, RS4) and dose (50 k digestible saccharide, 35 g by weight) were upshot coded. Subject was included as a random effect to business relationship for individual differences. Ii groups of analyses were used to determine furnishings of condition and dose. Experimental conditions were analyzed in groups based on the method of preparation. The first assay included the FDA standard testing conditions (50Dex, 50NWS, 50RS4). The second analysis included the market place exchange method conditions (35NWS, 35RS4) and the 50-k cracker atmospheric condition (50NWS, 50RS4). To determine the effect of condition, 50Dex, 50NWS, and 50RS4 were analyzed together as these weather condition were matched for digestible carbohydrate. To make up one's mind effects of dose, 50NWS, 50RS4, 35NWS, and 35RS4 were analyzed together and 50Dex was excluded from this analysis because there was not a low dose of dextrose used as a condition in this report. Mail service hoc comparisons were conducted for significant effects using the emmeans package in R. Consequence variables were transformed for normality according to Box Cox analyses using the MASS package in R. Specifically, a Box Cox assay was conducted which informed the type of transformation that should be used to transform each variable. Following the transformation of data, a histogram and residual plot were generated to verify the normal distribution of data. If >one transformation was identified using the Box Cox analysis, the transformation used was aligned according to similar variables. For example, if glucose iAUC was transformed via a square-root transformation and the Box Cox for insulin iAUC showed a log and foursquare-root transformation every bit potential options, both transformations were performed and histograms and residual plots were generated to find the normal distribution of data. If one of the transformations appeared drastically in favor of another potential transformation, and so that transformation was used. However, if both transformations yielded a like distribution of data, the square root transformation was used to align the insulin iAUC information with the glucose iAUC transformation. Glucose and insulin iAUCs were obtained using GraphPad Prism version 8.1.0 with the trapezoidal method (GraphPad Software, Inc.). Statistical significance was set at P< 0.05. Glucose peak, insulin peak, and insulin baseline-to-peak were log-transformed. Glucose iAUC, insulin iAUC, glucose baseline-to-tiptop, and insulin fourth dimension-to-peak were square-root transformed.

Missing values for glucose and insulin were due to intravenous catheter failure with participant refusal for placement of a new catheter and processing issues with insulin analysis of samples. All information nerveless via the catheter, during visits with catheter failure, were included in data analysis if they had passed a presumed summit following the i-h fourth dimension point.

Results

Xiv apparently good for you adults (nine males, 5 females) between the ages of 20 and 38 y completed the written report, with ane participant withdrawing following the second testing session (Figure 2). Demographic, anthropometric, baseline glucose, and baseline insulin results are shown inTable ii. Seven subjects were classified as overweight or obese [BMI (kg/m2) ≥24.9].

FIGURE 2

CONSORT diagram. CONSORT, Consolidated Standards of Reporting Trials.

Consort diagram. Espoused, Consolidated Standards of Reporting Trials.

FIGURE two

CONSORT diagram. CONSORT, Consolidated Standards of Reporting Trials.

Consort diagram. CONSORT, Consolidated Standards of Reporting Trials.

TABLE ii

Baseline participant characteristics of individuals who completed the report 1

All (n= fourteen)
Sexual activity (Yard:F), north 9:five
Age, y 24.half dozen ± 4.7
Height, cm 175.5 ± 8.8
Weight, kg 76.six ± xvi.8
Waist circumference, cm 87.ii ± 11.0
BMI, kg/one thousand2 24.viii ± 10.1
Torso fat (DXA), % 19.three ± 10.1
Fasting glucose, mg/dL 79.three ± 9.1
Fasting insulin, μIU/mL i.one ± 0.half dozen
All (northward= 14)
Sex (M:F), n ix:five
Age, y 24.6 ± 4.vii
Height, cm 175.v ± 8.8
Weight, kg 76.6 ± sixteen.eight
Waist circumference, cm 87.ii ± 11.0
BMI, kg/ktwo 24.eight ± x.1
Body fat (DXA), % 19.3 ± 10.1
Fasting glucose, mg/dL 79.three ± ix.1
Fasting insulin, μIU/mL 1.ane ± 0.6

1Values are means ± SDs unless otherwise indicated.

Table 2

Baseline participant characteristics of individuals who completed the study ane

All (n= xiv)
Sex (Grand:F), n 9:5
Historic period, y 24.6 ± four.7
Summit, cm 175.5 ± 8.8
Weight, kg 76.6 ± sixteen.eight
Waist circumference, cm 87.two ± eleven.0
BMI, kg/k2 24.8 ± 10.i
Body fatty (DXA), % xix.3 ± 10.1
Fasting glucose, mg/dL 79.three ± 9.one
Fasting insulin, μIU/mL 1.ane ± 0.six
All (northward= fourteen)
Sexual activity (Thou:F), n 9:5
Historic period, y 24.6 ± 4.7
Elevation, cm 175.5 ± viii.viii
Weight, kg 76.6 ± 16.viii
Waist circumference, cm 87.ii ± 11.0
BMI, kg/ktwo 24.viii ± x.1
Body fat (DXA), % 19.3 ± 10.1
Fasting glucose, mg/dL 79.3 ± 9.ane
Fasting insulin, μIU/mL 1.1 ± 0.6

1Values are means ± SDs unless otherwise indicated.

Comparison of fifty-g FDA standard testing method weather condition

When comparing the FDA standard testing protocol 50-g weather (50Dex, 50NWS, 50RS4) matched for digestible carbohydrate, consumption of both the 50NWS and 50RS4 crackers resulted in a lower glucose iAUC, glucose peak, and glucose baseline-to-peak when compared with 50Dex (all P< 0.001) (Figure ane andTable iii). Glucose iAUC was ∼58% lower, glucose elevation was ∼15% lower, and glucose baseline-to-acme was ∼45% lower for both cracker atmospheric condition when compared with 50Dex. However, no statistically significant differences were observed between the 50NWS and 50RS4 crackers (all P> 0.05). No differences were observed for glucose time-to-tiptop between 50-g weather (all P> 0.05). No differences were observed between 50-g weather for insulin iAUC, insulin peak, insulin baseline-to-height, or insulin time-to-peak (all P> 0.05). Results for 50-one thousand comparisons are displayed inTabular array 3.

Tabular array 3

Summary of means by testing method ane

Dextrose control (50Dex) FDA standard testing method (fifty thou matched digestible sugar) Exchange method (true-to-life) (35 m matched by weight)
Method and variable NWS RS4 P NWS RS4 P
Glucose
 iAUC, mg/dL × ii h 3016 (2115, 4076) 1251 (720, 1929) 1276 (739, 1960) 0.99 1317 (677, 2169) 701 (262, 1351) 0.37
 Height, mg/dL 134 (122, 147) 115.four (106.6, 124) 111.one (102.iii, 120) 0.61 104.3 (94.1, 114) 97.5 (87.4, 108) 0.70
 Baseline-to-peak, mg/dL 56.one (42.5, 71.5) 30.2 (21.7, twoscore.two) 32.0 (23.2, 42.ii) 0.98 28.2 (18.5, 39.9) 16.9 (9.61, 26.2) 0.xx
 Time-to-peak, min 34.three (27.0, 41.vi) 28.9 (21.9, 36.0) 27.nine (20.8, 34.nine) 0.99 46.1 (36.4, 55.8) 36.4 (26.7, 46.1) 0.50
Insulin
 iAUC, μIU/mL × 2 h 2470 (1836, 3199) 2311 (1820, 2861) 2330 (1836, 2882) 0.99 697 (397, 1080) 92 (10, 259) <0.01
 Tiptop, μIU/mL 42.iii (32.ii, 55.6) 47.9 (36.5, 63.0) 45.8 (34.9, 60.2) 0.58 21.7 (16.1, 29.4) xiii.3 (9.8, 17.ix) <0.01
 Baseline-to-meridian, μIU/mL 28.3 (17.1, 42.4) 38.0 (26.8, 53.9) 36.9 (26.0, 52.iii) 0.99 xiii.9 (nine.34, twenty.eight) iv.75 (3.18, 7.09) <0.01
 Time-to-top, min 49.3 (39.8, 58.8) 36.4 (29.iv, 43.4) 34.3 (27.3, 41.iii) 0.97 39.3 (29.8, 48.eight) 40.0 (30.5, 49.5) 0.99
Dextrose control (50Dex) FDA standard testing method (l g matched digestible saccharide) Exchange method (true-to-life) (35 k matched by weight)
Method and variable NWS RS4 P NWS RS4 P
Glucose
 iAUC, mg/dL × two h 3016 (2115, 4076) 1251 (720, 1929) 1276 (739, 1960) 0.99 1317 (677, 2169) 701 (262, 1351) 0.37
 Peak, mg/dL 134 (122, 147) 115.iv (106.6, 124) 111.1 (102.3, 120) 0.61 104.3 (94.1, 114) 97.5 (87.iv, 108) 0.70
 Baseline-to-acme, mg/dL 56.ane (42.v, 71.5) 30.ii (21.7, xl.two) 32.0 (23.2, 42.2) 0.98 28.2 (18.5, 39.9) xvi.9 (9.61, 26.2) 0.20
 Time-to-summit, min 34.three (27.0, 41.half-dozen) 28.9 (21.nine, 36.0) 27.9 (20.8, 34.nine) 0.99 46.1 (36.4, 55.8) 36.iv (26.7, 46.i) 0.fifty
Insulin
 iAUC, μIU/mL × 2 h 2470 (1836, 3199) 2311 (1820, 2861) 2330 (1836, 2882) 0.99 697 (397, 1080) 92 (x, 259) <0.01
 Peak, μIU/mL 42.three (32.2, 55.6) 47.9 (36.five, 63.0) 45.8 (34.9, 60.2) 0.58 21.seven (sixteen.ane, 29.4) 13.iii (nine.8, 17.nine) <0.01
 Baseline-to-peak, μIU/mL 28.3 (17.ane, 42.four) 38.0 (26.eight, 53.ix) 36.9 (26.0, 52.3) 0.99 13.9 (nine.34, xx.8) four.75 (three.18, 7.09) <0.01
 Time-to-acme, min 49.3 (39.8, 58.viii) 36.iv (29.4, 43.4) 34.iii (27.3, 41.3) 0.97 39.3 (29.eight, 48.8) 40.0 (thirty.5, 49.5) 0.99

1Values are ways (95% CIs). Testing method comparisons with the dextrose control drinkable are reported in the Results section. Statistical significance was ready at P< 0.05. P values indicate comparisons between cracker conditions. iAUC, incremental AUC; NWS, native wheat starch; RS4, resistant starch type iv; 50Dex, 50 g dextrose.

TABLE 3

Summary of means by testing method 1

Dextrose control (50Dex) FDA standard testing method (50 g matched digestible carbohydrate) Substitution method (true-to-life) (35 g matched past weight)
Method and variable NWS RS4 P NWS RS4 P
Glucose
 iAUC, mg/dL × 2 h 3016 (2115, 4076) 1251 (720, 1929) 1276 (739, 1960) 0.99 1317 (677, 2169) 701 (262, 1351) 0.37
 Peak, mg/dL 134 (122, 147) 115.4 (106.half dozen, 124) 111.1 (102.3, 120) 0.61 104.3 (94.i, 114) 97.5 (87.iv, 108) 0.70
 Baseline-to-superlative, mg/dL 56.i (42.5, 71.5) thirty.ii (21.7, 40.ii) 32.0 (23.2, 42.2) 0.98 28.ii (xviii.5, 39.9) 16.ix (9.61, 26.2) 0.twenty
 Time-to-top, min 34.iii (27.0, 41.6) 28.9 (21.nine, 36.0) 27.nine (20.eight, 34.nine) 0.99 46.1 (36.4, 55.8) 36.4 (26.vii, 46.1) 0.50
Insulin
 iAUC, μIU/mL × 2 h 2470 (1836, 3199) 2311 (1820, 2861) 2330 (1836, 2882) 0.99 697 (397, 1080) 92 (10, 259) <0.01
 Peak, μIU/mL 42.3 (32.2, 55.6) 47.9 (36.5, 63.0) 45.8 (34.nine, threescore.2) 0.58 21.7 (16.1, 29.4) xiii.three (9.8, 17.nine) <0.01
 Baseline-to-peak, μIU/mL 28.3 (17.ane, 42.four) 38.0 (26.eight, 53.9) 36.nine (26.0, 52.iii) 0.99 13.9 (9.34, 20.eight) 4.75 (3.18, 7.09) <0.01
 Time-to-acme, min 49.iii (39.eight, 58.8) 36.four (29.4, 43.iv) 34.iii (27.three, 41.three) 0.97 39.three (29.viii, 48.viii) 40.0 (30.5, 49.5) 0.99
Dextrose control (50Dex) FDA standard testing method (l yard matched digestible sugar) Exchange method (truthful-to-life) (35 yard matched by weight)
Method and variable NWS RS4 P NWS RS4 P
Glucose
 iAUC, mg/dL × 2 h 3016 (2115, 4076) 1251 (720, 1929) 1276 (739, 1960) 0.99 1317 (677, 2169) 701 (262, 1351) 0.37
 Summit, mg/dL 134 (122, 147) 115.4 (106.six, 124) 111.1 (102.3, 120) 0.61 104.3 (94.1, 114) 97.5 (87.four, 108) 0.70
 Baseline-to-peak, mg/dL 56.1 (42.5, 71.5) thirty.2 (21.7, xl.2) 32.0 (23.two, 42.2) 0.98 28.2 (xviii.five, 39.9) 16.9 (9.61, 26.2) 0.20
 Time-to-summit, min 34.iii (27.0, 41.vi) 28.9 (21.ix, 36.0) 27.9 (xx.8, 34.nine) 0.99 46.1 (36.4, 55.8) 36.four (26.7, 46.one) 0.50
Insulin
 iAUC, μIU/mL × 2 h 2470 (1836, 3199) 2311 (1820, 2861) 2330 (1836, 2882) 0.99 697 (397, 1080) 92 (10, 259) <0.01
 Height, μIU/mL 42.3 (32.two, 55.6) 47.ix (36.5, 63.0) 45.8 (34.9, 60.two) 0.58 21.seven (xvi.1, 29.4) 13.3 (ix.8, 17.9) <0.01
 Baseline-to-peak, μIU/mL 28.3 (17.1, 42.4) 38.0 (26.8, 53.9) 36.9 (26.0, 52.3) 0.99 13.9 (9.34, 20.eight) 4.75 (iii.18, 7.09) <0.01
 Fourth dimension-to-tiptop, min 49.3 (39.8, 58.8) 36.4 (29.4, 43.four) 34.3 (27.iii, 41.3) 0.97 39.iii (29.8, 48.8) 40.0 (30.five, 49.5) 0.99

1Values are means (95% CIs). Testing method comparisons with the dextrose control beverage are reported in the Results department. Statistical significance was ready at P< 0.05. P values betoken comparisons between cracker atmospheric condition. iAUC, incremental AUC; NWS, native wheat starch; RS4, resistant starch type four; 50Dex, 50 g dextrose.

Comparison of 35-g marketplace substitution method

Marketplace substitution cracker comparisons (35NWS, 35RS4) did not include the comparison with 50Dex. When comparison the 35-g conditions, there was no outcome of dose (P= 0.32), status (P= 0.17), or dose × condition (P= 0.22) for glucose iAUC, glucose peak, glucose baseline-to-tiptop, or glucose time-to-peak (all P> 0.05). However, there was a significant effect of dose (P< 0.0001), condition (P< 0.0001), and dose × status (P< 0.01) for insulin iAUC. The 35RS4 status elicited a lower insulin iAUC, insulin peak, and insulin baseline-to-peak compared with the 35NWS condition (all P< 0.01). Insulin iAUC was 87% lower for the 35RS4 condition compared with the 35NWS condition. Insulin peak was 39% lower for 35RS4 compared with 35NWS and insulin baseline-to-peak was 66% lower for 35RS4 compared with 35NWS. No differences were observed for insulin time-to-superlative (P> 0.05). Results for the 2 testing protocols (FDA and marketplace exchange) are compared inTable iii.

Discussion

In light of the prevalence of metabolic affliction globally and the promising enquiry on resistant starches thus far, the master aim of this study was to investigate glycemic and insulinemic responses to Fibersym® RW (RS4) crackers compared with NWS crackers. As office of this aim, nosotros compared RS4 and NWS nether 2 different testing protocols: the FDA standard testing protocol and the market place exchange method. When comparing the l-g atmospheric condition using the FDA standard testing protocol, glycemic responses to RS4 and NWS crackers were similar over a ii-h testing menstruation but differed considerably from dextrose. Similarly, the insulin responses did non differ between 50-g cracker conditions. We hypothesized that the RS4 cracker would elicit a lower glycemic and insulinemic response compared with the NWS cracker, regardless of the testing protocol used. The aught results can be explained given that the RS4 in the 50RS4 cracker condition was substituted for digestible carbohydrate in the 50NWS cracker condition, in accordance with the FDA standard testing method. This addition led to a 50RS4 condition containing a similar amount of digestible saccharide compared with the 50NWS condition, which could be expected to arm-twist a similar glycemic and insulinemic response. We hypothesize that these results may be due to the baking procedure used for the crackers, considering previous testing on RS4 in a nutrition bar, in accordance with the FDA standard testing protocol, has shown reduced glucose and insulin responses following training of nutrition confined as described previously (13).

When examining crackers made using the market place substitution method, without matching for digestible carbohydrate (35NWS, 35RS4), the insulinemic response was 87% lower for the 35RS4 cracker compared with the 35NWS cracker. Although the glycemic response to 35RS4 was ∼45% lower compared with 35NWS, at that place was not a statistically significant deviation between the 35-g cracker conditions. This was primarily due to large within-private variability within both 35-g cracker conditions (Tabular array 3). The lack of statistical differences in glycemic response betwixt the 35-g cracker conditions was surprising and did not support our original hypothesis. Previous inquiry has reported a reduced glycemic response to RS4 following both the FDA standard testing method and the marketplace substitution method (8, nine, 10, 13). Reduced insulin responses have been previously reported when investigating foods containing higher amounts of cobweb (20–,23). In addition, RS has been shown to arm-twist a reduced insulinemic response compared with foods matched for digestible carbohydrate or past weight (xiii, 24–26). Our results concord with these studies, as we showed reduced insulin responses following acute consumption of an RS4 cracker. Of particular interest, reduced insulin responses for RS4 and other types of RS, fifty-fifty when compared with foods eliciting like glycemic responses, is a recent finding that indicates a reduced load on the physiological systems of glucose control (7, 27). Additional research is needed to elucidate a potential benign issue of RS on insulin sensitivity.

The type of testing method for food products is important to consider, peculiarly when these products are being tested to obtain FDA food-label classifications. The current standard testing methods for products seeking a fiber food-label classification are to match both test and control foods by adding the test ingredient on meridian of the control food or by substituting the ingredient for a similar ingredient, while matching for digestible saccharide. From a physiological perspective, the addition of fiber on pinnacle of the fifty-yard saccharide corporeality may not produce a metabolic response to the examination food; it might simply delay that response or accept no effect, depending on the mechanism of action. Furthermore, when investigating high-fiber foods, the amount of product needed to elicit a marked change in glycemic or insulinemic response may not be known. This is particularly true when RSs are part of the product formulation, as researchers typically test at the fifty-g digestible sugar amount to preserve the power to detect differences where differences might be small. However, the 50-g saccharide corporeality represents a challenge for glucose and insulin testing in loftier-fiber foods considering l g of carbohydrate is probable to elicit a big glucose and insulin response, irrespective of fiber content.

The FDA testing methods may not stand for how an individual is probable to consume a cobweb ingredient in a fortified food. The FDA standard testing method of matching for digestible carbohydrate raises an boosted concern for testing loftier-fiber foods due to the depression digestible carbohydrate amount that some products contain. Low amounts of digestible sugar in products lead to testing that may apply drastically larger quantities of food than would typically be consumed past individuals. Further, this testing method could pb to multiple treatments that comprise drastically different amounts of nutrient. Theoretically, this could yield results that are primarily impacted past dissimilar mechanisms, and results that are potentially irrelevant to consumers if the products are not consumed in big quantities. It is important that the consumer knows how a given product may arm-twist a beneficial or harmful metabolic response. Consumers may exist trying to lose weight, meliorate metabolic health, or substitute more "healthful" products in place of less good for you options they would normally choose. Accurate information regarding more truthful-to-life metabolic responses to food products should be provided to consumers so that they tin can make informed choices regarding which products they would like to consume.

One argument in favor of using the FDA standard testing method is that it uses an approach that matches digestible saccharide, such that multiple treatments tin can be compared while adding a layer of control over the digestible sugar amounts of treatments. If beneficial metabolic outcomes are observed following acute consumption of high-cobweb products, then theoretically, they would deport over regardless of how consumers eat the products. Withal, beneficial metabolic effects may not be seen, compared confronting competing products, when these products are tested using lower amounts of the matched digestible carbohydrate. There may be a minimum dose of fiber necessary to arm-twist beneficial metabolic outcomes. According to the FDA Reference Amounts Customarily Consumed Per Eating Occasion, a typical serving size for crackers is ∼30 g per eating occasion (28). This reported amount is based on a per-weight footing, meaning the product would be made using the market substitution method and would correspond a product on the shelf of a grocery/convenience store. These differences observed between standard testing methods and the more true-to-life market place substitution testing method highlight an of import business organisation regarding how foods are tested compared with how they are sold and consumed.

At that place are several strengths of the current study that should be considered when evaluating the results. Strengths of this study include the novelty of the study design to parse apart differences between the FDA standard testing method and the more true-to-life marketplace exchange testing method where fiber is substituted in place of other saccharide ingredients but non matched for digestible carbohydrates. This study design elucidates a need for farther evaluation of the electric current FDA standard testing methods for glucose and insulin responses required for fiber food-label nomenclature. The single-blinded, randomized-controlled crossover trial design is another force of this study, as it allowed for multiple comparisons of cracker types and the method used to produce the cracker conditions, while minimizing within subject heterogeneity. The primary limitations of this study include the absence of a 35-g dextrose comparison, inhibiting our ability to straight compare the FDA standard testing method with the market substitution method for this saccharide amount. This condition was not included in lodge to limit participant burden. The pocket-sized sample size of man subjects is too a potential limitation. The use of the Bayer Contour glucometer is another potential limitation every bit this is a consumer-geared device that may not report the near authentic absolute glucose values. Although this is a potential limitation, this was accounted for with multiple measurements to ensure a more accurate measure out of absolute glucose values. A last limitation is the utilise of multiple comparisons, which inherently increases the potential for type I error. Futurity studies should investigate differences between FDA standard testing methods and market commutation methods with respect to glycemic and insulinemic responses using dissimilar products and different carbohydrate doses. In improver, broader populations should be investigated to determine whether like effects are observed, including populations with chronic conditions such as diabetes.

Our results signal differential outcomes using an FDA-approved protocol for testing of the glycemic and insulinemic responses to an RS4 and NWS cracker every bit opposed to a marketplace substitution protocol. The FDA standard testing method reported no differences between crackers at the 50-g digestible carbohydrate amount. All the same, at that place was a significantly lower postprandial insulinemic response for the RS4 cracker using the marketplace substitution method, matched by weight (35 1000) and non by carbohydrate amount, even with similar postprandial glycemic responses as compared with the NWS cracker. Given the potential of fiber, and more specifically RS, for improving metabolic responses, current testing for FDA claims on food labels should be evaluated farther to determine their appropriateness as compared with using more true-to-life testing amounts.

ACKNOWLEDGEMENTS

The authors' responsibilities were every bit follows—CCM, PAS, MDH, and SKR: designed the research; TJS: conducted the research and analyzed data; TJS and SKR: drafted the manuscript and had main responsibility for the final content; and all authors: read and approved the final manuscript.

Notes

This study was funded past MGP Ingredients, Inc. Insulin analyses were conducted at the Radioimmunoassay and Biomarkers Core of the University of Pennsylvania Diabetes Inquiry Center, supported past grant GM113109 from the National Institutes of General Medical Sciences.

Author disclosures: CCM works for MGP Ingredients, Inc. PAS is the inventor of cross-linked RS4 used in this study and has been a consultant for MGP Ingredients, Inc., for ≥20 years. The other authors report no conflicts of involvement. Both CCM and PAS were involved in study design; yet, neither CCM, PAS, nor MGP Ingredients, Inc., had any influence on data analysis or interpretation.

Abbreviations used: iAUC, incremental AUC; IPAQ-SF, International Concrete Activity Questionnaire–Short Form; NWS, native wheat starch; RS, resistant starch; RS4, resistant starch type four; 35RS4, 35 g of RS4 crackers by weight; 35NWS, 35 thou of NWS crackers by weight; 50Dex, 50 g dextrose potable; 50NWS, 50 g of digestible carbohydrate from NWS crackers; 50RS4, 50 g of digestible carbohydrate from RS4 and NWS crackers.

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