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Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals: a Pilot Study
Numerous evidences suggest an important role of short-chain fatty acids, produced by the intestinal fermentation of dietary fibers by the intestinal microbiota, in the modulation of various biological functions relevant to human health. In particular, butyrate, in addition to its trophic action on enterocytes, could improve insulin sensitivity and increase GLP-1 secretion, suggesting a possible role in the modulation of glucose metabolism. However, to date, very few randomized controlled trials (RCTs) have observed a significant increase in plasma butyrate concentrations in humans after nutritional interventions with high-fiber diets or foods. Butyrate occurs naturally in some foods, such as milk and dairy products, where it is often associated with sodium, becoming sodium butyrate. Therefore, recent studies suggest the use of oral sodium butyrate supplements in order to obtain a significant increase in butyrate plasma concentrations able to exert the potential beneficial effects related to them. To date, few studies have investigated the effect of oral sodium butyrate supplementation on glucose metabolism in healthy or overweight individuals, individuals at high cardiometabolic risk, and individuals with type 2 diabetes. Therefore, the purpose of this pilot study is to evaluate the effects of oral sodium butyrate supplementation, versus placebo, on glucose tolerance and insulin sensitivity in a group of overweight/obese individuals and the mechanisms underlying these effects.
Age
20 - 70 years
Sex
ALL
Healthy Volunteers
No
Federico II University, Department of Clinical Medicine and Surgery
Naples, Italy
Start Date
February 24, 2022
Primary Completion Date
March 15, 2023
Completion Date
June 13, 2023
Last Updated
February 7, 2024
14
ACTUAL participants
Supplementation with sodium- butyrrate
DIETARY_SUPPLEMENT
Placebo
DIETARY_SUPPLEMENT
Lead Sponsor
Federico II University
NCT07160400
NCT07150962
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06499857