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

Federico II University

Status: Completed

Conditions: Obesity; Type 2 Diabetes

Treatments: Dietary Supplement: Sodium Butyrate (NaBut); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07252609

44/2024

Details and patient eligibility

About

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

Enrollment: 46 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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46 participants in 2 patient groups, including a placebo group

Oral Sodium Butyrate Supplementation (NaBut)

Experimental group

Description:

Participants receive oral sodium butyrate (NaBut) in combination with a moderately hypocaloric diet. Sodium butyrate is administered in tablet form (Butir Bioma®, UNIFARCO S.p.A.), with each tablet containing 625 mg of sodium butyrate. Participants take one tablet three times daily-at breakfast, lunch, and dinner-for a total daily dose of 1,875 mg.

Treatment:

Dietary Supplement: Sodium Butyrate (NaBut)

Placebo

Placebo Comparator group

Description:

Participants receive placebo tablets in combination with the same moderately hypocaloric diet as the experimental group (NaBut arm). The placebo tablets are identical in appearance, weight, shape, color, and taste to the sodium butyrate tablets but do not contain the active ingredient (sodium butyrate). Participants take one placebo tablet three times daily-at breakfast, lunch, and dinner-for a total of three tablets per day.

Treatment:

Dietary Supplement: Placebo