RecruitingNot ApplicableNCT07165431

Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2).

Clinical Evaluation of a Postbiotic Supplement in Overweight and Obese Subjects: A Randomized Controlled Trial.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Enrollment

114 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Weight Loss Nutrition, Healthy Overweight and Obesity

Summary

The principal objective of this project is to evaluate the effect of a postbiotic supplement (inactivated microorganism) on body composition and other physiological and metabolic parameters related to excess body weight in overweight or obese adult men and women, as well as to determine changes in the gut microbiota associated with these outcomes. Specific objectives are focus on evaluate the effect of the intervention on the following parameters: * Changes in body weight and composition. * Changes in glucose tolerance. * Changes in gut microbiota (metagenomics). * Changes in urinary and serum metabolites. * Changes in routine biochemical variables related to carbohydrate and lipid metabolism, as well as liver parameters. * Changes in specific markers involved in obesity pathology, such as insulin, leptin, adiponectin, and cytokines MCP-1, TNF, CRP, and others. * Adherence to the nutritional recommendations and the gummy containing postbiotic formula. * Changes in the level of physical activity. Target sample size is 114 subjects, including a 10% of drop out. Participants will be allocated in two groups for 12 weeks: * Experimental group (n=57): nutritional recommendations + postbiotic supplement/gummy. * Placebo group (n=57): nutritional recommendations + placebo supplement/gummy. Participants will visit the nutritional intervention unit at weeks 1 and 12. A follow-up phone call will be conducted at week 6.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a postbiotic supplement — a preparation of heat-inactivated bacteria, which supports gut health without living organisms — can help reduce body weight and improve metabolic health in overweight or obese adults. **You may be eligible if...** - You are 18 to 70 years old - You are overweight or obese (BMI between 27 and 39.9) - Your body fat percentage is at least 30% (women) or 20% (men) - Your weight has been stable (within ±5%) for the past 3 months - You are in generally good health - Any ongoing medications have been at a stable dose for at least 3 months **You may NOT be eligible if...** - You have diabetes, serious heart disease, or significant metabolic disorders - You have had bariatric (weight loss) surgery - You are pregnant or breastfeeding - You are currently taking antibiotics or probiotic supplements - You have had significant changes in diet or weight recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTPostbiotic + nutritional recommendations

Study participants will consume daily one gummy containing a postbiotic formulation, along with adherence to healthy nutritional recommendations for 12 weeks.

DIETARY_SUPPLEMENTPlacebo + nutritional recommendations

Study participants will consume daily one gummy containing a placebo formulation, along with adherence to healthy nutritional recommendations for 12 weeks.