Clinical trial NCT06247020: Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals
Official title: Metabolic Effects of Oral Sodium Butyrate Supplementation on Overweight Individuals: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose Metabolism Disorders
Overweight or Obesity
Keywords: butyrate
sodium butyrate
short chain fatty acids
glucose
insulin
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Plasma glucose
timeFrame: one week
Secondary outcomes:
measure: Plasma insulin
timeFrame: one week
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Federico II University, Department of Clinical Medicine and Surgery
Study officials:
affiliation: Federico II University
name: Angela Albarosa Rivellese, PO
role: PRINCIPAL_INVESTIGATOR
References: