Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals

Federico II University

Status: Completed

Conditions: Overweight or Obesity; Glucose Metabolism Disorders

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Supplementation with sodium- butyrrate

Study type: Interventional

Funder types: Other

Identifiers

NCT06247020

368/19

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 2 patient groups, including a placebo group

Oral sodium-butyrrate supplementation

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Supplementation with sodium- butyrrate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo