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

Last updated: March 17, 2025
Sponsor: Bioithas SL
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypertriglyceridemia

Obesity

Treatment

Placebo

Probiotic

Clinical Study ID

NCT06815926
Probi.Obes
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, constantthroughout the study.

  • Signing of informed consent.

Exclusion

Exclusion Criteria:

  • Subjects with diabetes (type I or II), hypothyroidism or other diseases that maypromote weight gain.

  • Presence of other serious pathologies, including cancer or autoimmune diseases, orany other that, at the medical discretion of the investigator, may influence theresults of the study.

  • Subjects who have participated in a weight loss program or who have substantiallymodified their lifestyle habits (diet, physical exercise) during the previous 3months.

  • Treatment with antibiotics in the previous 4 weeks.

  • Consumption of products or drugs intended for weight loss or satiety control, orthat 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 orintolerance to any of its ingredients.

  • In the case of women: pregnancy or breastfeeding, or plans to become pregnant duringthe course of the study.

Study Design

Total Participants: 104
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
February 12, 2025
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • MiBioPath Research Group (UCAM)

    Murcia,
    Spain

    Active - Recruiting

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