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

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.

Conditions

• Nutrition, Healthy
• Weight Loss
• Overweight and Obesity

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.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

  lead OTHER

Principal Investigators

• Paula Aranaz, PhD · Center for Nutrition Research

• Fermín Milagro, PhD · Center for Nutrition Research

• Idoia Ibero, PhD · Center for Nutrition Research

• Blanca Martínez · Center for Nutrition Research

• María Goñi · Center for Nutrition Research

• Salomé Pérez · Center for Nutrition Research

• Verónica Ciaurriz · Center for Nutrition Research

• Ana Lorente · Center for Nutrition Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2026-05-30

Completion

2026-06-30

Countries

• Spain

Study Locations