Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes

Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes

The goal of this clinical trial (randomized controlled trial with parallel group design) is to evaluate the effects of oral sodium butyrate supplementation for 12 weeks, compared with placebo, in addition to a moderately hypocaloric diet, on body weight, body composition, glucose metabolism, and lipid metabolism in overweight or obese individuals with and without type 2 diabetes.

The main questions this study aims to answer are:

• Does oral sodium butyrate improve body weight reduction and body composition compared with placebo?
• Does it improve glucose and lipid metabolism in participants with and without type 2 diabetes?

The study includes 46 men and women aged 30-70 years, with overweight or obesity (BMI 25-39.9 kg/m²) and HbA1c ≤ 7.0%. Participants are randomly assigned to receive either oral sodium butyrate or placebo, both combined with a moderately hypocaloric diet for 12 weeks.

Participants:

• Take sodium butyrate tablets (625 mg three times daily; total 1,875 mg/day) or placebo tablets with meals
• Follow a personalized, balanced hypocaloric diet monitored by a dietitian
• Attend clinic visits every two weeks for anthropometric measurements and dietary adherence checks
• Complete a 7-day food diary and a gastrointestinal symptom questionnaire (PAGI-SYM)
• Undergo fasting blood tests, body composition analysis (bioelectrical impedance), and continuous glucose monitoring (CGM) at baseline and after 12 weeks

Inclusion Criteria:

• Men and women with overweight or obesity (Body Mass Index [BMI] between 25.0 and 39.9 kg/m²), with or without type 2 diabetes Age between 30 and 70 years HbA1c ≤ 7.5%

Exclusion Criteria:

• Cardiovascular events (myocardial infarction and/or stroke) within the previous 6 months
• Renal insufficiency (serum creatinine > 1.5 mg/dL) or hepatic impairment (ALT or AST levels more than twice the upper limit of normal)
• Anemia (hemoglobin < 12 g/dL)
• Insulin therapy or use of antihyperglycemic drugs other than metformin
• Use of antibiotics, probiotics, or prebiotics within the previous 3 months
• Habitual intense physical activity
• Pregnancy or breastfeeding