Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes
NCT ID: NCT07252609
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2024-11-13
2025-08-08
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. oral supplementation with sodium butyrate (NaBut) + hypocaloric diet, or
2. oral supplementation with placebo + hypocaloric diet.
TREATMENT
SINGLE
Study Groups
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Oral Sodium Butyrate Supplementation (NaBut)
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.
Sodium Butyrate (NaBut)
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
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.
Placebo
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.
Interventions
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Sodium Butyrate (NaBut)
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
30 Years
70 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Giuseppina Costabile
Senior Researcher
Principal Investigators
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Lutgarda Bozzetto, Full Professor
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
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Federico II University
Napoli, , Italy
Countries
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Other Identifiers
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44/2024
Identifier Type: -
Identifier Source: org_study_id
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