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

NCT07252609 | Completed DMC

• 1 other identifier: 44/2024
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity; Type 2 Diabetes

Keywords

Butyrate; body weight; obesity; type 2 diabetes; butyrate supplementation; glucose control; lipid metabolism

Outcome Measures

Primary Outcomes (1)

• Reduction in Body Weight After 12 Weeks of Oral Sodium Butyrate Supplementation Compared With Placebo

  Body weight is measured at baseline and after 12 weeks of treatment. The primary outcome is the reduction in body weight (kg) from baseline to week 12 between the sodium butyrate and placebo groups.

  baseline and 12 weeks

Secondary Outcomes (12)

• Change in Body Composition (Fat Mass, Lean Mass, and Fat-Free Mass)

  baseline and 12 weeks

• Changes in Continuous Glucose Monitoring (CGM) Parameters

  baseline and 12 weeks

• Changes in Fasting Glucose

  Baseline and 12 weeks

• Changes in fasting insulin

  Baseline and 12 weeks

• Changes in glycated hemoglobin (HbA1c)

  Baseline and 12 weeks

Study Arms (2)

Oral Sodium Butyrate Supplementation (NaBut)

EXPERIMENTAL

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.

Dietary Supplement: Sodium Butyrate (NaBut)

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Sodium Butyrate (NaBut) DIETARY_SUPPLEMENT

Participants receive oral sodium butyrate (NaBut) in combination with a moderately hypocaloric diet for 12 weeks. Sodium butyrate is administered as 625 mg tablets (Butir Bioma®, UNIFARCO S.p.A.), taken three times daily with meals (breakfast, lunch, and dinner), for a total daily dose of 1,875 mg. The hypocaloric diet is individualized based on basal metabolic rate (measured by indirect calorimetry) and physical activity level, with a 300-500 kcal/day energy reduction.

Oral Sodium Butyrate Supplementation (NaBut)

Placebo DIETARY_SUPPLEMENT

Participants receive placebo tablets identical in appearance, weight, shape, color, smell, and taste to the sodium butyrate tablets but without the active ingredient, combined with the same moderately hypocaloric diet as the experimental group. Tablets are taken three times daily with meals (breakfast, lunch, and dinner), for a total of three tablets per day. The hypocaloric diet follows the same composition and energy restriction as described for the sodium butyrate intervention.

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Federico II University

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Body Weight

Interventions

Butyric Acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Lutgarda Bozzetto, Full Professor

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Model Details: The experimental study will be conducted according to a randomized parallel-group design, involving 46 obese individuals, with and without type 2 diabetes. The experimental phase will be preceded by a 3-week observation period (run-in), during which participants will stabilize their habitual diet. At the end of this period, participants will be randomly assigned to one of two 12-week treatments: 1. oral supplementation with sodium butyrate (NaBut) + hypocaloric diet, or 2. oral supplementation with placebo + hypocaloric diet.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 26, 2025
• Study Start: November 13, 2024
• Primary Completion: August 8, 2025
• Study Completion: August 8, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)