Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals

NCT06247020 | Completed

• 1 other identifier: 368/19
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 overweight/obese individuals and the mechanisms underlying these effects.

Conditions

Glucose Metabolism Disorders; Overweight or Obesity

Keywords

butyrate; sodium butyrate; short chain fatty acids; glucose; insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Plasma insulin

  one week

Study Arms (2)

Oral sodium-butyrrate supplementation

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Supplementation with sodium- butyrrate DIETARY_SUPPLEMENT

Oral supplementation with sodium butyrrate capsules

Oral sodium-butyrrate supplementation

Placebo DIETARY_SUPPLEMENT

Oral supplementation with placebo capsules

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index: 25-30 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University, Department of Clinical Medicine and Surgery

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Glucose Metabolism Disorders; Overweight; Obesity; Insulin Resistance

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Angela Albarosa Rivellese, PO

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 7, 2024
• Study Start: February 24, 2022
• Primary Completion: March 15, 2023
• Study Completion: June 13, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

IT (1)