Federico II University, Department of Clinical Medicine and Surgery
Naples, 80131, Italy
NCT Number: NCT06247020
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.
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Notify Me20 year–70 year
All sexes
Interventional
Not applicable
Naples, 80131, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral supplementation with sodium butyrrate capsules
Oral supplementation with placebo capsules
Time frame: one week
The primary outcome of the study is the improvement of the glucose response during an oral glucose tolerance test (OGTT) after the supplementation with sodium butyrate, without changes in body weight
Time frame: one week
The secondary outcome of the study is the improvement of the insulin response during an oral glucose tolerance test (OGTT) after the supplementation with sodium butyrate, without changes in body weightglycemic and insulinemic response during an OGTT separately in men and women
Federico II University
Other
Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals: a Pilot Study
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