Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals
- Conditions
- Glucose Metabolism DisordersOverweight or Obesity
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Supplementation with sodium- butyrrate
- Registration Number
- NCT06247020
- Lead Sponsor
- Federico II University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
- Body Mass Index: 25-30 kg/m2
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo 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 Oral sodium-butyrrate supplementation Supplementation with sodium- butyrrate 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.
- Primary Outcome Measures
Name Time Method Plasma glucose 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 Outcome Measures
Name Time Method Plasma insulin 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
Trial Locations
- Locations (1)
Federico II University, Department of Clinical Medicine and Surgery
🇮🇹Naples, Italy