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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Composition (Fat Mass, Lean Mass, and Fat-Free Mass) | 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. | baseline and 12 weeks |
| Changes in Continuous Glucose Monitoring (CGM) Parameters |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lutgarda Bozzetto, Full Professor | Federico II University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federico II University | Naples | 80131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41880673 | Derived | Testa R, Vitale M, Giosue A, Salamone D, Quaglia C, Rivellese AA, Bozzetto L, Costabile G. Targeting weight loss and blood glucose control with oral sodium butyrate in overweight/obese adults with and without type 2 diabetes: A proof-of-concept randomized controlled trial. Clin Nutr. 2026 May;60:106624. doi: 10.1016/j.clnu.2026.106624. Epub 2026 Mar 11. |
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no secure institutional infrastructure is currently available to support anonymized data sharing
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020148 | Butyric Acid |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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:
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|
| 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. |
|
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. |
| baseline and 12 weeks |
| Changes in Fasting Glucose | Fasting plasma glucose is assessed at baseline and at week 12 by immunoenzymatic assay; results are reported in mg/dl | Baseline and 12 weeks |
| Changes in fasting insulin | Fasting plasma insulin is assessed at baseline and at week 12 by ELISA method and expressed in µU/ml | Baseline and 12 weeks |
| Changes in glycated hemoglobin (HbA1c) | 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 %. | Baseline and 12 weeks |
| Changes in serum lipids | 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 | Baseline and 12 weeks |
| Changes in Short-Chain Fatty Acids (SCFA) | 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 | Baseline and 12 weeks |
| Changes in Intestinal Permeability Markers_Zonulin | Fasting serum zonulin, as a biomarker of intestinal permeability, is measured at baseline and after 12 weeks by ELISA and expressed in ng/mL | Baseline and 12 weeks |
| Changes in Intestinal Permeability Markers_LPS | Fasting serum lipopolysaccharide (LPS), a biomarker of intestinal permeability, is measured at baseline and after 12 weeks by ELISA and expressed in pg/mL | Baseline and 12 weeks |
| Changes in Inflammatory Markers_hsCRP | 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 | Baseline and 12 weeks |
| Changes in Gut Microbiota Composition | 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 | baseline and 12 weeks |
| Changes in Inflammatory Markers_TNFalfa_IL-6 | 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 | Baseline and 12 weeks |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005232 |
| Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |