Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals

NCT ID: NCT06247020

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-24
• Study Completion Date: 2023-06-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Supplementation with sodium- butyrrate

Intervention Type: DIETARY_SUPPLEMENT

Oral supplementation with sodium butyrrate capsules

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Oral supplementation with placebo capsules

Interventions

Supplementation with sodium- butyrrate

Oral supplementation with sodium butyrrate capsules

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Oral supplementation with placebo capsules

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

rivellese angela

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Angela Albarosa Rivellese, PO

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

Federico II University, Department of Clinical Medicine and Surgery

Naples, , Italy

Countries

Italy

Other Identifiers

368/19

Identifier Type: -

Identifier Source: org_study_id