Active — Not RecruitingNot Applicable

Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents

Spain70 participantsStarted 2024-04-10

Plain-language summary

This study investigates the effects of a postbiotic combination called ABB C3 on reducing body fat and improving metabolic health in children and teenagers. The study consists of a 3-month trial with half participants taking ABB C3 and the other half a placebo, monitoring body composition and blood markers. Afterward, participants can continue with ABB C3 for an additional 3 months. The goal is to determine if ABB C3 is a safe and effective way to help young people improve their health by reducing body fat.

Who can participate

Age range8 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 8- and 18-year-old * Obesity (BMI-SDS \> 2) Exclusion Criteria: * Antibiotic or pre/pro/postbiotic consumption 2 - 4 weeks prior to starting the study * Chronic diseases affecting glucose or lipid metabolism * Chronic medication affecting glucose or lipid metabolism, or inducing a pro-inflammatory state * History of bariatric surgery * Diabetes requiring insulin treatment * Severe intellectual disability * Pregnancy * Individuals taking medications that may alter appetite or weight, with a recent change in prescription within the last 3 months or anticipated changes during the 2 months of participation

What they're measuring

Incidence of Adverse Events

Timeframe: Baseline, 1.5 months, 3 months

Change in adiposity (% fat body mass)

Timeframe: 3 months

Change in blood glycated hemoglobin (HbA1c) levels

Timeframe: 3 months

Trial details

NCT IDNCT06309121

SponsorFundació Sant Joan de Déu

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Obesity, Childhood trials