Clinical trial

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

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT06309121

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Childhood, Obesity, Adolescent

Full registry criteria

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

Treatments and study arms

Postbiotic ABB C3

Dietary Supplement

A daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for the first 3 months of the study.

Placebo

Dietary Supplement

A daily dose of 550 mg of the placebo in individual sachets for the first 3 months of the study.

Follow-up Postbiotic ABB C3 (Optional)

Dietary Supplement

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.

Primary outcomes

Incidence of Adverse EventsBaseline, 1.5 months, 3 months

Treatment safety and tolerability will be evaluated by assessing differences in the incidence of potential adverse events between groups, focusing on gastrointestinal symptoms.

Change in adiposity (% fat body mass)3 months

Fat body mass (adiposity) will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline and 3 months and differences will be assessed

Change in blood glycated hemoglobin (HbA1c) levels3 months

Blood tests will be performed at baseline and 3 months and HbA1c (%) levels quantified.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Hospital Sant Joan de Déu🇪🇸 Barcelona, Barcelona, Spain

Open map