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

Study acronym: PARABIOTICS-2
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 19, 2026 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07165431
Lead Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Conditions
(from sponsor)		 Nutrition, Healthy, Weight Loss, Overweight and Obesity
Related terms Obesity, Overweight, Weight Loss
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov