Glucose Metabolism Disorders, Overweight or Obesity
Conditions
Keywords
butyrate, sodium butyrate, short chain fatty acids, glucose, insulin
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.
Interventions
DIETARY_SUPPLEMENTSupplementation with sodium- butyrrate
Oral supplementation with sodium butyrrate capsules
DIETARY_SUPPLEMENTPlacebo
Oral supplementation with placebo capsules
Sponsors
Federico II University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed