Evaluating a Probiotic Product for Weight Loss
Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Probiotic Product in Weight Control
This study is testing whether a probiotic supplement can help people who are overweight or mildly obese lose weight over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bioithas SL Industry-sponsored |
| Locations | 1 site (Murcia) |
| Trial ID | NCT06815926 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a probiotic food supplement in reducing body weight among individuals with overweight and Grade I obesity. The study involves 104 volunteers who will participate in a randomized, double-blind, placebo-controlled design over a 12-week period, where participants will take either the probiotic or a placebo daily. The trial aims to explore the relationship between gut microbiota and weight management, contributing to the growing interest in probiotics as alternative treatments for obesity. Participants are required to maintain their lifestyle habits throughout the study.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 18 and older with a BMI between 25.0 and 34.9 who are committed to maintaining their lifestyle during the study.
Not a fit: Patients with diabetes, serious pathologies, or those who have recently altered their lifestyle or taken weight loss medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel approach to weight management through the use of probiotics.
How similar studies have performed: Other studies have shown promising results with probiotics for weight management, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Men and women aged ≥ 18 years. * Body Mass Index (BMI) between 25.0 and 34.9 (overweight or obesity type I). * Commitment to maintaining a lifestyle, including diet and sports habits, constant throughout the study. * Signing of informed consent. Exclusion Criteria: * Subjects with diabetes (type I or II), hypothyroidism or other diseases that may promote weight gain. * Presence of other serious pathologies, including cancer or autoimmune diseases, or any other that, at the medical discretion of the investigator, may influence the results of the study. * Subjects who have participated in a weight loss program or who have substantially modified their lifestyle habits (diet, physical exercise) during the previous 3 months. * Treatment with antibiotics in the previous 4 weeks. * Consumption of products or drugs intended for weight loss or satiety control, or that may influence weight in the previous 4 weeks. * Consumption of products containing probiotics in the previous 2 months. * Contraindication to taking the product under investigation, or allergy or intolerance to any of its ingredients. * In the case of women: pregnancy or breastfeeding, or plans to become pregnant during the course of the study.
Where this trial is running
Murcia
- MiBioPath Research Group (UCAM) — Murcia, Spain (Recruiting)
Study contacts
- Study coordinator: BIOITHAS Clinical Research Department
- Email: ensayosclinicos@bioithas.com
- Phone: +34623012586
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.