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

Bioithas SL106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

106

Conditions

Overweight, Obesity Grade I

Interventions

ProbioticDIETARY_SUPPLEMENT

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.

PlaceboDIETARY_SUPPLEMENT

Food supplement in capsule format. Dose: 1 capsule/day. The placebo capsules contain only excipient (probiotics are not included).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

MiBioPath Research Group (UCAM)

Murcia, Spain

Outcomes

Primary Outcomes

Changes in body weight between baseline and 6- and 12-weeks

Time frame: Baseline, 6-week and 12-week

Changes in body mass index (BMI) baseline and 6- and 12-weeks

Time frame: Baseline, 6-week and 12-week

Secondary Outcomes

Changes in waist/hip circumference ratio between baseline and 6- and 12-weeks

Time frame: Baseline, 6-week and 12-week

Changes in body composition between baseline and 12-weeks

Body composition is assessed by DEXA (Dual-Energy X-ray Absorptiometry). Lean mass and fat mass of the different body regions will be measured as grams (g) and percentage (%).