An interventional study of Supplementation with sodium- butyrrate and Placebo in Glucose Metabolism Disorders and Overweight or Obesity, sponsored by Federico II University. Completed at 1 site in Italy. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-02-07.
Sponsored by Federico II University · Not applicable, Interventional, and Prevention
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 14 is below the median of 73 across 3,175 interventional studies indexed under Overweight.
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Exclusion Criteria:
Participants consumed 8 capsules of sodium butyrate per day for a week. The capsules were consumed with main meals (2 for breakfast, 2 for lunch and 2 for dinner). Each capsule contained 200 mg of sodium butyrate, for a total of 1.6 grams of sodium butyrate per day.
Dietary Supplement: Supplementation with sodium- butyrrate
Participants consumed 8 capsules of placebo. The capsules were consumed with main meals (2 for breakfast, 2 for lunch and 2 for dinner). Each capsule contained cornstarch
Dietary Supplement: Placebo
Oral supplementation with sodium butyrrate capsules
Oral supplementation with placebo capsules
Plasma glucose
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
Plasma insulin
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
Time frame: one week
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Federico II University