ObesityButRedNCT07252609
Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes
A study testing Sodium Butyrate (NaBut) in people with Obesity and Type 2 Diabetes, run by Federico II University at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Sodium Butyrate (NaBut)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 13 Nov 2024to 8 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
- Being tested
- Sodium Butyrate (NaBut), Placebo
- Keywords
- Butyrate, body weight, obesity, type 2 diabetes, butyrate supplementation, glucose control, lipid metabolism
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 12 weeks
Secondary outcomes (12)
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.
Measured: baseline and 12 weeks
Changes in Continuous Glucose Monitoring (CGM) Parameters
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.
Measured: 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
Measured: 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
Measured: 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 %.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start13 Nov 2024
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppina Costabile, Federico II University
- Investigators
- Lutgarda Bozzetto, Full Professor, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252609
- Sponsor's protocol ID
- 44/2024
- Acronym
- ButRed
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no secure institutional infrastructure is currently available to support anonymized data sharing
Publications
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.
PubMed 41880673
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07252609
- Acronym / sponsor ID
- ButRed / 44/2024
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Butyrate, body weight, obesity, type 2 diabetes, butyrate supplementation, glucose control, lipid metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oral Sodium Butyrate Supplementation (NaBut) | Experimental | Dietary Supplement: Sodium Butyrate (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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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%
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Oral Sodium Butyrate Supplementation (NaBut) |
| PlaceboParticipants 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. | Dietary supplement | Placebo |
Primary outcome
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.
12 secondary outcomes
Change in Body Composition (Fat Mass, Lean Mass, and Fat-Free Mass)
Time frame: baseline and 12 weeks
Changes in Continuous Glucose Monitoring (CGM) Parameters
Time frame: baseline and 12 weeks
Changes in Fasting Glucose
Time frame: Baseline and 12 weeks
Changes in fasting insulin
Time frame: Baseline and 12 weeks
Changes in glycated hemoglobin (HbA1c)
Time frame: Baseline and 12 weeks
Changes in serum lipids
Time frame: Baseline and 12 weeks
Changes in Short-Chain Fatty Acids (SCFA)
Time frame: Baseline and 12 weeks
Changes in Intestinal Permeability Markers_Zonulin
Time frame: Baseline and 12 weeks
Changes in Intestinal Permeability Markers_LPS
Time frame: Baseline and 12 weeks
Changes in Inflammatory Markers_hsCRP
Time frame: Baseline and 12 weeks
Changes in Gut Microbiota Composition
Time frame: baseline and 12 weeks
Changes in Inflammatory Markers_TNFalfa_IL-6
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Derived from this study: PubMed 41880673Testa 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.
- Individual participant dataSharing planned: No. no secure institutional infrastructure is currently available to support anonymized data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lutgarda Bozzetto, Full Professor principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium Butyrate (NaBut) in people with Obesity and Type 2 Diabetes, run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Body Weight After 12 Weeks of Oral Sodium Butyrate Supplementation Compared With Placebo (time frame: baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07252609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.