Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247020
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2024-01-15
Brief Title:
Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals
Sponsor:
Federico II University
Organization:
Federico II University
Study Overview
Official Title:
Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals a Pilot Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 overweightobese individuals and the mechanisms underlying these effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None