NCT07165431

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 114 (estimated)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Volunteers who wish to participate in the study will complete an online questionnaire to verify eligibility based on the main inclusion criteria. Volunteers who meet these criteria will be invited to an information and screening visit to address any questions. Those who agree to participate will sign the informed consent form, be randomly assigned to one of the two study arms, and receive the necessary study materials. During the intervention, volunteers will attend two clinical investigation visits. The Clinical Investigation Day 1 will be conducted on the first day of the study, and the Clinical Investigation Day 2 visit will occur at the end of the 12-week intervention. At both visits, anthropometric and body composition measurements, blood pressure, and samples of blood, urine, and stool will be collected. Additionally, data on diet, physical activity, sleep, and gastrointestinal symptoms will be recorded.

Conditions

• Nutrition, Healthy
• Weight Loss
• Overweight and Obesity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Postbiotic + nutritional recommendations	Study participants will consume daily one gummy containing a postbiotic formulation, along with adherence to healthy nutritional recommendations for 12 weeks.
DIETARY_SUPPLEMENT	Placebo + nutritional recommendations	Study participants will consume daily one gummy containing a placebo formulation, along with adherence to healthy nutritional recommendations for 12 weeks.

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-05-30
• Completion: 2026-06-30
• First posted: 2025-09-10
• Last updated: 2026-02-19

Locations

1 site across 1 country: Spain