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

Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of a Probiotic Product in Weight Control

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 Overview

• Status: Completed
• Conditions: Overweight, Obesity Grade I
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Murcia, Spain
    • MiBioPath Research Group (UCAM)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: PLACEBO	Dietary supplement: Placebo; Food supplement in capsule format. Dose: 1 capsule/day. The placebo capsules contain only excipient (probiotics are not included).
Experimental: PROBIOTIC	Dietary supplement: Probiotic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 (%).	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	Alpha diversity, beta diversity and bacterial taxonomic composition of the gut microbiota will be assessed by sequencing the 16S rRNA gene of stool samples.	Baseline and 12-week
Changes in the score of gastrointestinal symptoms questionnaire between baseline and 6- and 12-weeks	Questionnaire with 15 questions related to gastrointestinal discomfort during the last month. Each question is valued according to: None = 1; Insignificant = 2; Mild = 3; Moderate = 4; Quite strong = 5; Strong = 6; and Very strong = 7. The total score is calculated by adding the number of answers answered for the different degrees of discomfort (1-7), and is between 15 and 105 points. The higher the score, the worse the indication of gastrointestinal symptoms.	Baseline, 6-week and 12-week
Changes in the score of International Physical Activity Questionnaire (IPAQ) between baseline and 12-weeks	International Physical Activity Questionnaire (IPAQ) measures the time spent being physically active during the past 7 days. The type of activity is divided into: vigorous activity, moderate activity, walking, and no activity (sitting). Weekly activity is recorded in Mets (Metabolic Equivalent of Task or Metabolic Rate Units) per minute and week. The reference Mets values are: Walking: 3.3 Mets.; Moderate physical activity: 4 Mets.; Intense physical activity: 8 Mets. To obtain the total number of Mets, the reference Mets values are multiplied by the time in minutes of performing each type of activity in a day and by the number of days per week that it is performed. Depending on the number of Mets, physical activity is categorized as high, moderate, or low.	Baseline and 12-week
Changes in the MEDiterranean LIFEstyle index (MEDLIFE) questionnaire between baseline and 12-weeks	The MEDiterranean LIFEstyle index (MEDLIFE) consists of 28 questions categorized into three blocks: 1. Consumption of Mediterranean foods (15 questions); 2. Mediterranean dietary habits (7 questions); and 3. Physical activity, rest, social habits and coexistence (6 questions). Each question is scored with 0 or 1 point depending on whether or not it meets the established criteria, so the total score is between 0 and 28 points (the higher the score, the greater the adherence to the Mediterranean lifestyle).	Baseline and 12-week
Changes in the score of the Simplified Nutritional Appetite Questionnaire (SNAQ) between baseline and 12-weeks	Simplified Nutritional Appetite Questionnaire (SNAQ) The questionnaire consists of 4 questions. The results are scored on the following numerical scale: a 1, b 2, c 3, d 4, e 5. The sum of the scores for the individual items constitutes the SNAQ score. The total score ranges from 5 to 20 points.	Baseline and 12-week
Changes in blood count between baseline and 12-weeks	Values of complete blood count.	Baseline and 12-week
Changes in glucose levels between baseline and 12-weeks	Blood glucose values.	Baseline and 12-week
Changes in insulin levels between baseline and 12-weeks	Blood insulin values.	Baseline and 12-week
Changes in glycosylated hemoglobin (HbA1c) levels between baseline and 12-weeks	Blood glycosylated hemoglobin (HbA1c) values.	Baseline and 12-week
Changes in LDL and HDL, and total cholesterol levels between baseline and 12-weeks	Blood LDL and HDL, and total cholesterol values.	Baseline and 12-week
Changes in triglycerides levels between baseline and 12-weeks	Blood triglycerides values.	Baseline and 12-week
Changes in creatinine and urea levels between baseline and 12-weeks	Blood creatinine and urea values.	Baseline and 12-week
Changes in AST/GOT and ALT/GPT levels between baseline and 12-weeks	Blood AST/GOT and ALT/GPT values.	Baseline and 12-week
Changes in C-reactive protein levels between baseline and 12-weeks	Blood C-reactive protein values.	Baseline and 12-week
Changes in leptin levels between baseline and 12-weeks	Blood leptin values.	Baseline and 12-week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs)	AEs reported by participants, whether or not related to the intake of the investigational products, including required pharmacological treatments if applicable.	6-week and 12-week
Adherence rate to the investigational product	Adherence is assessed through leftover capsules and days between visits.	6-week and 12-week

Collaborators and Investigators

• Sponsor: Bioithas SL

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Actual): July 3, 2025
• Study Completion (Actual): July 3, 2025

Study Registration Dates

• First Submitted: February 4, 2025
• First Submitted That Met QC Criteria: February 4, 2025
• First Posted (Actual): February 10, 2025

Study Record Updates

• Last Update Posted (Actual): July 17, 2025
• Last Update Submitted That Met QC Criteria: July 16, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: obesity; overweight; probiotics; food supplement; gut microbiota
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: Probi.Obes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No