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Active Not RecruitingNCT06309121

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

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
70 (estimated)
Sponsor
Fundació Sant Joan de Déu · Academic / Other
Sex
All
Age
8 Years – 18 Years
Healthy volunteers
Not accepted

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.

Detailed description

The study focuses on evaluating the effects of a combination of postbiotics called ABB C3 in reducing body fat and improving glucose metabolism. The study proposes a randomized, double-blind clinical trial with participants (aged 8-18 years) randomized into the ABB C3 supplement group or a placebo group. Over a period of 3 months, body composition and relevant blood parameters will be monitored (Study Phase). Subsequently, all participants will be offered to continue with the ABB C3 supplement for an additional 3 months, constituting the Follow-up Phase. The study protocol includes collecting data on possible adverse events. Blood samples and DXA scans will be performed to assess changes in body composition and metabolic health parameters. In summary, the study aims to determine the efficacy and safety of the ABB C3 postbiotic in helping reduce body fat and improve metabolic profiles in children and adolescents.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPostbiotic ABB C3A daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for the first 3 months of the study.
DIETARY_SUPPLEMENTPlaceboA daily dose of 550 mg of the placebo in individual sachets for the first 3 months of the study.
DIETARY_SUPPLEMENTFollow-up Postbiotic ABB C3 (Optional)Option given to all participants: a daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for months 4 to 6 of the study.

Timeline

Start date
2024-04-10
Primary completion
2025-12-31
Completion
2026-06-30
First posted
2024-03-13
Last updated
2026-03-23

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT06309121. Inclusion in this directory is not an endorsement.