Acute glycemic and insulin response of Fossence™ alone, or when substituted or added to a carbohydrate challenge: A three-phase, acute, randomized, cross-over, double blind clinical trial

Abstract

Short chain fructo-oligosaccharides (scFOS) are well-recognized prebiotic fibers. Fossence™ (FOSS) is a scFOS that has been produced from sucrose via a proprietary fermentation process and has not been tested for its digestibility or glucose/insulin response (GR and IR, respectively). The present randomized, controlled, cross-over study was conducted in 3 phases to explore GR and IR to ingestion of FOSS, when replaced by/added to available-carbohydrates (avCHO) among 25 healthy adults (40 ± 14years). In each phase GR and IR elicited by 3-4 test-meals were measured among the fasted recruited subjects. The interventional test meals were as follows: Phase-1, water alone or 10g FOSS or 10g Dextrose in 250ml water; Phase-2, 250ml water containing Dextrose:FOSS (g:g) in the content as 50:0 or 50:15 or 35:0 or 35:15; Phase-3 portions of white-bread (WB) containing avCHO:FOSS (g:g) in the content as 50:0 or 50:15 or 35:0 or 35:15. Blood samples (finger prick method) were collected at fasting and 15, 30, 45, 60, 90 and 120 min after start of test meal ingestion. Plasma glucose and serum insulin were analyzed utilizing standard methods. The primary endpoint was differences in glucose IAUC. All subjects provided their written consent to participate in the study (ClinicalTrials.gov: NCT03755232). The results demonstrated that FOSS, when consumed alone, showed no raise in glycaemia or insulinemia and was statistically equivalent to response of water alone. GR and IR elicited by dextrose:FOSS and WB:FOSS test-meals of Phase 2 and Phase 3, were statistically equivalent to the respective test-meals without FOSS. Result of the 3 phases support the hypothesis that FOSS is resistant to breakdown and is indigestible in the human small-intestine, and therefore can be classified as an unavailable carbohydrate that does not raise post prandial blood glucose or insulin. FOSS, being sweet to taste, may be an acceptable sugar replacer in beverages without compromising their taste and sensory qualities.

Keywords: Glycemic response; Insulin response; Non-digestible carbohydrates; Prebiotic fiber; Short chain fructo-oligosaccharides; Sugar substitute.

Conflict of interest statement

The authors declare the following conflict of interests: Priyali Shah, Manish Jain, Manoj Gote, Anirban Bhaduri are employees of Tata Chemicals Limited, India. Ashim Mullick is employee of Tata Consumers Products Limited [former employee of Tata Chemicals Limited, India]. Alexandra Jenkins, Thomas Wolever, Adish Ezatagha, Janice Campbell, Andreea Zurbau; are employees of INQUIS Clinical Research Inc.

© 2021 Published by Elsevier Ltd.

Figures

Figure 1

Glucose and Insulin Responses. Values are means ± SEM for n = 25 subjects. Panels A, C and E show plasma glucose; panels B, D and F show serum insulin. Phase 1 is shown in panels A and B (Dex10 = 10g dextrose, F10 = 10g FOSS), Phase 2 in panels C and D (Dex50 = 50g dextrose; Dex35 = 35g dextrose; F15 = 15g FOSS) and Phase 3 in panels E and F (WB50 = 51.9g available carbohydrate from white bread; WB35 = 35.1g available carbohydrate from white bread; F15 = 15g FOSS). ab means with different letter superscripts differ by Tukey's test, p < 0.05. D = significant main effect of Dose (35g differs from 50g) by ANOVA, p < 0.05.

Figure 2

Equivalence tests. Dex = dextrose; WB = white bread; FOSS = Fossence™; GR = glycemic response; IR = insulinemic response; iAUC = incremental area under the curve. Top Panel: comparisons of the effects of Dex or WB plus FOSS vs Dex or WB alone on glucose and insulin responses (eg. for Dex, % difference = (100% × Dex + FOSSiAUC/DexiAUC) -100, where Dex + FOSSiAUC = mean iAUC for Dex35 + FOSS15 and Dex50 + FOSS15 doses of Dex + FOSS and DexiAUC = mean iAUC for Dex35 and Dex50). Bottom panel: comparisons of the effects of 35g vs 50g available carbohydrate (avCHO) doses of Dex or WB on glucose and insulin responses (eg. for GR after Dex, % difference = (100% × Dex35iAUC/Dex50iAUC) - 80.6, where Dex35iAUC = mean iAUC for Dex35 + FOSS15 and Dex35; Dex50iAUC = mean iAUC for Dex50 + FOSS15 and Dex50; and 80.6 = the expected relative response; see text under Statistical analysis, Phases 2 and 3). Blue and red diamonds are the mean differences for glucose and insulin, respectively, the error bars are the 95% confidence intervals of the differences after excluding outliers (see Table 3) and the blue and red dashed lines are the equivalence margins (±20% of expected relative GR and ±22.8% of expected relative IR).