NCT06247020

Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals

Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals: a Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Federico II University · Academic / Other
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glucose Metabolism Disorders
• Overweight or Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Supplementation with sodium- butyrrate	Oral supplementation with sodium butyrrate capsules
DIETARY_SUPPLEMENT	Placebo	Oral supplementation with placebo capsules

Timeline

• Start date: 2022-02-24
• Primary completion: 2023-03-15
• Completion: 2023-06-13
• First posted: 2024-02-07
• Last updated: 2024-02-07

Locations

1 site across 1 country: Italy