Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals

Glucose Metabolism Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06247020
• Other study ID #: 368/19
• Status: Completed
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: June 13, 2023

Study information

• Verified date: February 2024
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 13, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Body Mass Index: 25-30 kg/m2

Exclusion Criteria:

• type 2 diabetes,

• treatment with antibiotics within the past 3 months

• history of gastrointestinal diseases (Inflammatory bowel disease, Crohn's disease, malabsorption etc )

• cardiovascular events (myocardial infarction or stroke) during the 6-12 months prior to the study

• thyroid disorders not controlled by drug therapy,

• kidney (creatinine >1.7 mg/dl or proteinuria) and liver diseases (ALT/AST >twice the upper limits)

• anaemia (Hb <12 g /dl)

• pregnancy or breastfeeding,

• celiac disease, cancer or any other chronic disease

Related Conditions & MeSH terms

• Glucose Metabolism Disorders
• Metabolic Diseases
• Overweight
• Overweight or Obesity

Intervention

Dietary Supplement:
• Supplementation with sodium- butyrrate
Oral supplementation with sodium butyrrate capsules
• Placebo
Oral supplementation with placebo capsules

Locations

Country	Name	City	State
Italy	Federico II University, Department of Clinical Medicine and Surgery	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one week
Secondary	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	one week