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Completed

NCT Number: NCT06247020

Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University, Department of Clinical Medicine and Surgery

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Supplementation with sodium- butyrrate

Dietary Supplement

Oral supplementation with sodium butyrrate capsules

Placebo

Dietary Supplement

Oral supplementation with placebo capsules

Primary outcomes

  1. Plasma glucose

    Time frame: one week

    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

Secondary outcomes

  1. Plasma insulin

    Time frame: one week

    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

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2024
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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