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RECRUITING
NCT07165431
NA

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

Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2025-12-01

Completion Date

2026-06-30

Last Updated

2026-02-19

Healthy Volunteers

Yes

Interventions

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.

Locations (1)

Center for Nutrition Research

Pamplona, Navarre, Spain