Effects of Oral Sodium Butyrate Supplementation on Body Weight Reduction in Overweight/Obese Individuals With and Without Type 2 Diabetes

Plain-language summary

This study looks at the effects of oral Sodium Butyrate (NaBut) supplementation on body weight reduction, compared with placebo, in overweight or obese people. It enrolled people aged 30 to 70 with a body mass index between 25.0 and 39.9 kg/m², with or without type 2 diabetes. It is a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Federico II University

Intervention

Sodium Butyrate (NaBut), Placebo

Start date

11/13/2024

Estimated completion

8/8/2025

Countries

Italy

Related genes

Locations

• Naples, Italy

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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