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

N/AActive Not RecruitingNCT06309121

Fundació Sant Joan de Déu70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obesity, Childhood

Interventions

Postbiotic ABB C3DIETARY_SUPPLEMENT

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

PlaceboDIETARY_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.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Sant Joan de Déu

Barcelona, Barcelona, Spain

Outcomes

Primary Outcomes

Incidence of Adverse Events

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

Time frame: Baseline, 1.5 months, 3 months

Change in adiposity (% fat body mass)

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

Time frame: 3 months

Change in blood glycated hemoglobin (HbA1c) levels

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

Time frame: 3 months

Secondary Outcomes

Change in adiposity (% fat body mass)

Fat body mass (adiposity) will be assessed by dual energy x-ray absorptiometry (DXA) scan at baseline and 6 months and differences will be assessed.

Time frame: Baseline, 6 months

Change in blood glycated hemoglobin (HbA1c) levels

Blood tests will be performed at baseline and 6 months and HbA1c (%) levels quantified. Differences between time-points will be assessed.

Time frame: Baseline, 6 months

Change in BMI z-score

Weight and height will be combined to calculate changes in BMI and BMI z scores and differences between time-points will be assessed.

Time frame: Baseline, 1.5 months, 3 months, 6 months

Change in body composition

Body composition (lean and fat mass) will be estimated by bioimpedance and differences between time-points will be assessed.

Time frame: Baseline, 1.5 months, 3 months, 6 months

Change in insulin sensitivity

Fasting blood glucose and insulin concentrations will be combined to calculate HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) and differences between time-points will be assessed