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

NCT06309121 | Active Not Recruiting

• 1 other identifier: PIC-11-24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Childhood; Obesity, Adolescent

Keywords

Obesity; Postbiotics

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  3 months

• Change in blood glycated hemoglobin (HbA1c) levels

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

  3 months

Secondary Outcomes (9)

• Change in adiposity (% fat body mass)

  Baseline, 6 months

• Change in blood glycated hemoglobin (HbA1c) levels

  Baseline, 6 months

• Change in BMI z-score

  Baseline, 1.5 months, 3 months, 6 months

• Change in body composition

  Baseline, 1.5 months, 3 months, 6 months

• Change in insulin sensitivity

  Baseline, 3 months, 6 months

Other Outcomes (2)

• Change in gut microbial abundance and diversity

  Baseline, 3 months, 6 months

• Change in plasma metabolite concentrations

  Baseline, 3 months, 6 months

Study Arms (2)

Active control

PLACEBO COMPARATOR

Participants in this arm will receive the usual treatment for obesity at our hospital, based on lifestyle changes (encouraging a healthy diet and physical activity) for 3 months. Participants will receive a daily dose of placebo for these 3 months, then given the option to receive a daily dose of probiotic ABB C3 for 3 more months.

Dietary Supplement: Placebo; Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional)

Treatment

EXPERIMENTAL

Participants in this arm will receive the usual treatment for obesity at our hospital, based on lifestyle changes (encouraging a healthy diet and physical activity) for 3 months. Participants will receive a daily dose of postbiotic blend (ABB C3) for these 3 months, then given the option to receive a daily dose of probiotic ABB C3 for 3 more months.

Dietary Supplement: Postbiotic ABB C3; Dietary Supplement: Follow-up Postbiotic ABB C3 (Optional)

Interventions

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.

Treatment

Placebo DIETARY_SUPPLEMENT

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

Active control

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.

Active control; Treatment

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 8- and 18-year-old
• Obesity (BMI-SDS \> 2)

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Sant Joan de Déu: lead

Study Sites (1)

Hospital Sant Joan de Déu

Barcelona, Barcelona, 08950, Spain

Location

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Carles Lerin, PhD

  Fundació Sant Joan de Deu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blind placebo-controlled study with a treatment group and an active control parallel group.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 13, 2024
• Study Start: April 10, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)