Clinical trial NCT06815926: Clinical Trial to Evaluate the Effect of a Probiotic Product on Weight
Official title: Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Probiotic Product in Weight Control
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight, Obesity Grade I
Keywords: probiotics
overweight
obesity
food supplement
gut microbiota
Lead sponsor: Bioithas SL
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Changes in body weight between baseline and 6- and 12-weeks
timeFrame: Baseline, 6-week and 12-week
measure: Changes in body mass index (BMI) baseline and 6- and 12-weeks
timeFrame: Baseline, 6-week and 12-week
Secondary outcomes:
measure: Changes in waist/hip circumference ratio between baseline and 6- and 12-weeks
timeFrame: Baseline, 6-week and 12-week
measure: Changes in body composition between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in blood pressure between baseline and 6- and 12-weeks
timeFrame: Baseline, 6-week and 12-week
measure: Changes in gut microbiota composition between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in the score of gastrointestinal symptoms questionnaire between baseline and 6- and 12-weeks
timeFrame: Baseline, 6-week and 12-week
measure: Changes in the score of International Physical Activity Questionnaire (IPAQ) between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in the MEDiterranean LIFEstyle index (MEDLIFE) questionnaire between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in the score of the Simplified Nutritional Appetite Questionnaire (SNAQ) between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in blood count between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in glucose levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in insulin levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in glycosylated hemoglobin (HbA1c) levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in LDL and HDL, and total cholesterol levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in triglycerides levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in creatinine and urea levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in AST/GOT and ALT/GPT levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in C-reactive protein levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
measure: Changes in leptin levels between baseline and 12-weeks
timeFrame: Baseline and 12-week
Other outcomes:
measure: Adverse events (AEs)
timeFrame: 6-week and 12-week
measure: Adherence rate to the investigational product
timeFrame: 6-week and 12-week
Locations:
city: Murcia
country: Spain
facility: MiBioPath Research Group (UCAM)
Study officials:
References: