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

NCT06815926 | Completed

• 1 other identifier: Probi.Obes
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight, Obesity Grade I

Keywords

probiotics; overweight; obesity; food supplement; gut microbiota

Outcome Measures

Primary Outcomes (2)

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

  Baseline, 6-week and 12-week

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

  Baseline, 6-week and 12-week

Secondary Outcomes (18)

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

  Baseline, 6-week and 12-week

• Changes in body composition between baseline and 12-weeks

  Baseline and 12-week

• Changes in blood pressure between baseline and 6- and 12-weeks

  Baseline, 6-week and 12-week

• Changes in gut microbiota composition between baseline and 12-weeks

  Baseline and 12-week

• Changes in the score of gastrointestinal symptoms questionnaire between baseline and 6- and 12-weeks

  Baseline, 6-week and 12-week

Other Outcomes (2)

• Adverse events (AEs)

  6-week and 12-week

• Adherence rate to the investigational product

  6-week and 12-week

Study Arms (2)

PROBIOTIC

EXPERIMENTAL

Dietary Supplement: Probiotic

PLACEBO

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_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.

PROBIOTIC

Placebo DIETARY_SUPPLEMENT

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

PLACEBO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bioithas SL: lead

Study Sites (1)

MiBioPath Research Group (UCAM)

Murcia, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 10, 2025
• Study Start: February 12, 2025
• Primary Completion: July 3, 2025
• Study Completion: July 3, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

ES (1)