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

Bioithas

Status

Completed

Conditions

Overweight, Obesity Grade I

Treatments

Dietary Supplement: Probiotic

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT06815926

Probi.Obes

Details and patient eligibility

About

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.

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.