Last reviewed · How we verify
NCT07252609: ButRed
Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes
NA trial testing Sodium Butyrate (NaBut) in Obesity in 46 participants. Completed in 8 August 2025.
8 August 2025
Quick facts
| Lead sponsor | Federico II University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 13 November 2024 |
| Primary completion | 8 August 2025 |
| Estimated completion | 8 August 2025 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Sodium Butyrate (NaBut)
- Placebo
Conditions studied
- Obesity — all drugs for Obesity →
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Federico II University
Who can join
Adults 30 to 70, any sex, with Obesity or Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
Testa R, Vitale M, Giosuè A, Salamone D, et al · · 2026 · PMID 41880673 · DOI 10.1016/j.clnu.2026.106624
Verify or expand the search:
- PubMed search for NCT07252609
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Obesity
Currently open trials in the same condition.
- NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
- NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
- NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting
Other Federico II University trials
Trials by the same sponsor.
- NCT07437690 — Fall Prevention in Older Adults in an Italian Cohort · not yet recruiting
- NCT07282132 — Evaluation of Real-World Data on Ropeginterferon Alfa-2b in Patients With Polycythemia Vera: Insights From a Multicenter · not yet recruiting
- NCT07280286 — Incidence of Intrauterine Adhesions After Myomectomy With Intrauterine Anti-Adhesion Gel · NA · not yet recruiting
- NCT07374861 — Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy · recruiting
- NCT07314684 — GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07252609 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federico II University
- Last refreshed: 26 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07252609.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing