NCT06815926

Clinical Trial to Evaluate the Effect of a Probiotic Product on Weight

Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Probiotic Product in Weight Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Bioithas SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study of the intestinal microbiota and its relationship with health and disease, as well as the use of probiotics as effective alternative treatments to improve people's well-being is a field of growing research in recent years. Overweight and obesity are increasingly common due to the current lifestyle, but this is not incompatible with the growing interest of the population in taking care of themselves, both physically and psychologically, and, in general, the interest in food supplements, including those based on probiotics, is increasingly common. The objective of the clinical trial is to evaluate the effectiveness of a food supplement based on probiotics to reduce body weight in 104 volunteers with overweight and type I obesity (BMI 25 - 34.9 kg/m2). This randomized, double-blind and placebo-controlled clinical trial has a 12-week intervention period, during which subjects have to take a daily dose of the product (probiotic or placebo). In this trial, anthropometric clinical data, the effect of the intervention on blood parameters and the composition of the intestinal microbiota will be analyzed.

Conditions

• Overweight, Obesity Grade I

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Food supplement based on probiotics in capsule format. Dose: 1 capsule/day. The active capsules contain probiotic strains at ≥1×10\^9 cfu/dose and excipient.
DIETARY_SUPPLEMENT	Placebo	Food supplement in capsule format. Dose: 1 capsule/day. The placebo capsules contain only excipient (probiotics are not included).

Timeline

• Start date: 2025-02-12
• Primary completion: 2025-07-03
• Completion: 2025-07-03
• First posted: 2025-02-10
• Last updated: 2025-07-17

Locations

1 site across 1 country: Spain