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NCT Number: NCT07252609

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

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federico II University

Naples, 80131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: baseline and 12 weeks

    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.

Secondary outcomes

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

    Time frame: baseline and 12 weeks

    Body composition is assessed by bioelectrical impedance analysis (BIA) at baseline and after 12 weeks to evaluate changes in fat mass, lean mass, and fat-free mass between groups.

  2. Changes in Continuous Glucose Monitoring (CGM) Parameters

    Time frame: baseline and 12 weeks

    Continuous glucose monitoring (CGM) is performed for 7 days at baseline and at the end of treatment to evaluate mean glucose levels, variability, and time-in-range between groups.

  3. Changes in Fasting Glucose

    Time frame: Baseline and 12 weeks

    Fasting plasma glucose is assessed at baseline and at week 12 by immunoenzymatic assay; results are reported in mg/dl

  4. Changes in fasting insulin

    Time frame: Baseline and 12 weeks

    Fasting plasma insulin is assessed at baseline and at week 12 by ELISA method and expressed in µU/ml

  5. Changes in glycated hemoglobin (HbA1c)

    Time frame: Baseline and 12 weeks

    Glycated hemoglobin (HbA1c) was measured at baseline and after 12 weeks in fasting whole-blood samples by high-performance liquid chromatography (HPLC) and was expressed as mmol/mol and %.

  6. Changes in serum lipids

    Time frame: Baseline and 12 weeks

    Fasting serum triglycerides, total cholesterol and HDL cholesterol are evaluated at baseline and after 12 weeks using immunoenzymatic methods and all expressed in mg/dL

  7. Changes in Short-Chain Fatty Acids (SCFA)

    Time frame: Baseline and 12 weeks

    Serum concentrations of short-chain fatty acids (acetate, propionate, butyrate) are measured at baseline and after 12 weeks.

    SCFA levels are assessed as metabolic markers of gut microbial activity and host metabolic response to sodium butyrate supplementation. They were quantified by gas chromatography with flame ionization detection (GC/FID) and expressed in μmol/L

  8. Changes in Intestinal Permeability Markers_Zonulin

    Time frame: Baseline and 12 weeks

    Fasting serum zonulin, as a biomarker of intestinal permeability, is measured at baseline and after 12 weeks by ELISA and expressed in ng/mL

  9. Changes in Intestinal Permeability Markers_LPS

    Time frame: Baseline and 12 weeks

    Fasting serum lipopolysaccharide (LPS), a biomarker of intestinal permeability, is measured at baseline and after 12 weeks by ELISA and expressed in pg/mL

  10. Changes in Inflammatory Markers_hsCRP

    Time frame: Baseline and 12 weeks

    Serum high-sensitivity C-reactive protein (hs-CRP) concentrations are measured at baseline and after 12 weeks using immunoturbidimetric methods and expressed in mg/dL

  11. Changes in Gut Microbiota Composition

    Time frame: baseline and 12 weeks

    Fecal samples are collected at baseline and after 12 weeks to evaluate the effects of sodium butyrate on gut microbiota composition, compared to placebo. Microbial community structure is analyzed using 16S rRNA gene sequencing and shotgun metagenomic techniques to assess taxonomic and functional changes

  12. Changes in Inflammatory Markers_TNFalfa_IL-6

    Time frame: Baseline and 12 weeks

    Serum tumor necrosis factor-alpha (TNF-α) and interleukin-6 (IL-6) concentrations are measured at baseline and after 12 weeks using ELISA and are expressed in pg/mL

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Acronym: ButRed

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 26, 2025
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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