Dataset Information

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.

SUBMITTER: Shah P

PROVIDER: S-EPMC8102419 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Abstract Objectives To explore the physiological response to ingestion of FossenceTM, a short chain fructo-oligosaccharide, when taken alone or when added or substituted into a carbohydrate load. Methods In a randomized, controlled, cross-over design, 25 healthy subjects completed three phases (phase 1: 13M:12F; 41 ± 14y; 24.4 ± 2.2 kg/m²; phase 2: 13M:12F; 40 ± 14y; 24.5 ± 2.4 kg/m²; phase 3: 13M:12F; 41 ± 14y; 24.3 ± 2.6 kg/m²; Mean ± SD). On separate days, each subject received in Phase 1: 10 g FossenceTM(10FOS), 10 g Dextrose (10Dex) or a water control (Control); Phase 2: 50 g Dextrose alone (50Dex), Dextrose with 15 g FossenceTM(50Dex + 15FOS), 35 g Dextrose alone (35Dex) or Dextrose with 15 g FossenceTM(35Dex + 15FOS); and Phase 3 received: 50 g available carbohydrate (avCHO) from white bread alone (50WB) or with 15 g FossenceTM(50WB + 15FOS), 35 g avCHO from white bread alone (35WB) or with 15 g FossenceTM(35WB + 15FOS). Blood samples were collected at fasting and over 2 hours after the start of the test meal and analyzed for glucose and insulin levels. The primary endpoint was differences in glucose IAUC. (ClinicalTrials.gov: NCT03755232). Results Phase 1: The glucose IAUC was significantly lower after 10FOS and Control compared to 10Dex (P < 0.0001). Similarly, the insulin IAUC was significantly lower after Control and 10FOS compared to 10Dex (P < 0.0001). Phase 2: The glucose IAUC was significantly lower after 35Dex and 35Dex + 15FOS compared to 50Dex (P < 0.0001). Insulin IAUC was significantly lower after 35Dex compared to 50Dex and 50Dex + 15FOS, the IAUC of 35Dex + 15FOS was significantly lower than 50Dex (P < 0.0003). Phase 3: The glucose IAUC was significantly lower after 35WB and 35WB + 15FOS compared to 50WB and 50WB + 15FOS (P < 0.00001). Insulin IAUC was significantly lower after 35WB and 35WB + 15FOS compared to 50WB and 50WB + 15FOS (P < 0.00001). Conclusions These studies demonstrate that FossenceTM, when consumed alone, does not increase postprandial glucose and insulin levels, indicating it is resistant to breakdown. When added to a carbohydrate load, no increase in postprandial glucose or insulin levels is observed while substitution of 30% of glycemic carbohydrate by FossenceTMsignificantly decreased postprandial glucose and insulin levels. FossenceTM, being sweet to taste, may be advised to individuals on restricted sugar intake. Funding Sources Tata Chemicals Ltd, India.

Project description:IntroductionMaintenance of drug efficacy and safety over the long term is important to investigate for progressive conditions like type 2 diabetes mellitus (T2DM). This study aimed to evaluate whether efficacy of dapagliflozin added to glimepiride observed at 24 weeks was maintained at 48 weeks, and to provide further safety and tolerability data in patients with T2DM.MethodsThis 24-week randomized, double-blind, parallel-group, placebo-controlled trial with a 24-week double-blind extension period enrolled adults whose T2DM was inadequately controlled [glycated hemoglobin (HbA1c) 7.0-10.0%] on sulfonylurea monotherapy. Patients were randomized to placebo (n = 146) or dapagliflozin 2.5 mg (n = 154), 5 mg (n = 145), or 10 mg (n = 151) per day added to open-label glimepiride 4 mg/day.ResultsIn total, 519 patients (87.1%) completed the study. At 48 weeks, HbA1c adjusted mean changes from baseline for the placebo versus dapagliflozin 2.5/5/10-mg groups were -0.04% versus -0.41%, -0.56% and -0.73%, respectively. There were no meaningful differences in HbA1c changes from baseline from 24 to 48 weeks, indicating that glycemic efficacy was maintained. Improvements in fasting plasma glucose and post-challenge plasma glucose were also observed with dapagliflozin over 48 weeks. Dapagliflozin 2.5/5/10 mg produced sustained reductions in weight (-1.36/-1.54/-2.41 kg) versus placebo (-0.77 kg). Adjusted mean reductions from baseline in systolic blood pressure were also greater than placebo for all dapagliflozin doses. In the placebo versus dapagliflozin groups, serious adverse events were 8.9% versus 8.6-11.0%, hypoglycemic events were 6.8% versus 9.7-11.3%, and events suggestive of genital infection were 1.4% versus 5.2-8.6%.ConclusionDapagliflozin added to glimepiride improved glycemic control and body weight, with short-term findings maintained during the study's extension period. Therapy was generally well tolerated over 48 weeks; hypoglycemic events and events suggestive of genital infection were reported more often in patients receiving dapagliflozin.

Project description:1. The regulatory effects that adenine nucleotides are known to exert on enzymes of glycolysis and gluconeogenesis were demonstrated to operate in kidney-cortex slices and in the isolated perfused rat kidney by the addition of exogenous ATP, ADP and AMP to the incubation or perfusion media. 2. Both preparations rapidly converted added ATP into ADP and AMP, and ADP into AMP; added AMP was rapidly dephosphorylated. AMP formed from ATP was dephosphorylated at a lower rate than was added AMP, especially when the initial ATP concentration was high (10mm). Deamination of added AMP occurred more slowly than dephosphorylation of AMP. 3. Gluconeogenesis from lactate or propionate by rat kidney-cortex slices, and from lactate by the isolated perfused rat kidney, was inhibited by the addition of adenine nucleotides to the incubation or perfusion media. In contrast, oxygen consumption and the utilization of propionate or lactate by slices were not significantly affected by added ATP or AMP. 4. The extent and rapidity of onset of the inhibition of renal gluconeogenesis were proportional to the AMP concentration in the medium and the tissue, and were not due to the production of acid or P(i) or the formation of complexes with Mg(2+) ions. 5. Glucose uptake by kidney-cortex slices was stimulated 30-50% by added ATP, but the extra glucose removed was not oxidized to carbon dioxide and did not all appear as lactate. Glucose uptake, but not lactate production, by the isolated perfused kidney was also stimulated by the addition of ATP or AMP. 6. In the presence of either glucose or lactate, ATP and AMP greatly increased the concentrations of C(3) phosphorylated intermediates and fructose 1,6-diphosphate in the kidney. There was a simultaneous rise in the concentration of malate and fall in the concentration of alpha-oxoglutarate. 7. The effects of added adenine nucleotides on renal carbohydrate metabolism seem to be mainly due to an increased concentration of intracellular AMP, which inhibits fructose diphosphatase and deinhibits phosphofructokinase. This conclusion is supported by the accumulation of intermediates of the glycolytic pathway between fructose diphosphate and pyruvate. 8. ATP or ADP (10mm) added to the medium perfusing an isolated rat kidney temporarily increased the renal vascular resistance, greatly diminishing the flow rate of perfusion medium for a period of several minutes.

Project description:BackgroundThe quality of carbohydrate consumed, assessed by the glycemic index (GI), glycemic load (GL), or carbohydrate quality index (CQI), affects the postprandial glycemic and insulinemic responses, which have been implicated in the etiology of several chronic diseases. However, it is unclear whether plasma metabolites involved in different biological pathways could provide functional insights into the role of carbohydrate quality indices in health.ObjectivesWe aimed to identify plasma metabolomic profiles associated with dietary GI, GL, and CQI.MethodsThe present study is a cross-sectional analysis of 1833 participants with overweight/obesity (mean age = 67 y) from 2 case-cohort studies nested within the PREDIMED (Prevención con Dieta Mediterránea) trial. Data extracted from validated FFQs were used to estimate the GI, GL, and CQI. Plasma concentrations of 385 metabolites were profiled with LC coupled to MS and associations of these metabolites with those indices were assessed with elastic net regression analyses.ResultsA total of 58, 18, and 57 metabolites were selected for GI, GL, and CQI, respectively. Choline, cotinine, γ-butyrobetaine, and 36:3 phosphatidylserine plasmalogen were positively associated with GI and GL, whereas they were negatively associated with CQI. Fructose-glucose-galactose was negatively and positively associated with GI/GL and CQI, respectively. Consistent associations of 21 metabolites with both GI and CQI were found but in opposite directions. Negative associations of kynurenic acid, 22:1 sphingomyelin, and 38:6 phosphatidylethanolamine, as well as positive associations of 32:1 phosphatidylcholine with GI and GL were also observed. Pearson correlation coefficients between GI, GL, and CQI and the metabolomic profiles were 0.30, 0.22, and 0.27, respectively.ConclusionsThe GI, GL, and CQI were associated with specific metabolomic profiles in a Mediterranean population at high cardiovascular disease risk. Our findings may help in understanding the role of dietary carbohydrate indices in the development of cardiometabolic disorders. This trial was registered at isrctn.com as ISRCTN35739639.

Dataset Information

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.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets