Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals

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

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.

Study Overview

• Status: Completed
• Conditions: Glucose Metabolism Disorders; Overweight or Obesity
• Intervention / Treatment: Dietary supplement: Supplementation with sodium- butyrrate; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Federico II University, Department of Clinical Medicine and Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral sodium-butyrrate supplementation; 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; Oral supplementation with sodium butyrrate capsules
Placebo Comparator: Placebo; 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 placebo capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Federico II University
• Investigators: Principal Investigator: Angela Albarosa Rivellese, PO, Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): June 13, 2023

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Estimated): February 7, 2024

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: insulin; glucose; short chain fatty acids; butyrate; sodium butyrate
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight; Metabolic Diseases; Glucose Metabolism Disorders
• Other Study ID Numbers: 368/19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No