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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity, Childhood; Obesity, Adolescent
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Follow-up Postbiotic ABB C3 (Optional); Dietary supplement: Postbiotic ABB C3

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta Ramon Krauel, MD, PhD; Phone Number: 71263 (+34) 932804000; Email: marta.ramon@sjd.es

Study Locations

• Spain
  • Barcelona, Spain, 08950
    • Recruiting
    • Hospital Sant Joan de Déu
    • Principal Investigator: Carles Lerin, PhD
    • Contact: Marta Ramon Krauel, MD PhD; Phone Number: 71263 (+34) 932804000; Email: marta.ramon@sjd.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Active control; 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; A daily dose of 550 mg of the placebo in individual sachets for the first 3 months of the study.; Dietary supplement: Follow-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.
Experimental: Treatment; 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: Follow-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.; Dietary supplement: Postbiotic ABB C3; A daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for the first 3 months of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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	Baseline, 3 months, 6 months
Change in lipid profile (triglycerides, cholesterol)	The lipid profile will be determined by blood test and differences between time-points will be assessed	Baseline, 3 months, 6 months
Change in blood pressure	Both systolic and diastolic blood pressure will be measured at each visit and differences between time-points will be assessed	Baseline, 3 months, 6 months
Change in Beck Depression Inventory-II (BDI-2)	The Beck Depression Inventory for Youth (BDI-2) assesses negative thoughts of children or adolescents about themselves, their life, and their future, along with feelings of sadness and physiological signs of depression. It is a 20-item questionnaire with a score range of 0-60. Higher scores indicate worse outcome.	Baseline, 3 months, 6 months
Change in Beck Anxiety Inventory-II (BAI-2)	The Beck Anxiety Inventory for Youth (BAI-2) assesses the fears and concerns of children or adolescents, as well as physical symptoms associated with anxiety. It is a 20-item questionnaire with a score range of 0-60. Higher scores indicate worse outcome.	Baseline, 3 months, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gut microbial abundance and diversity	DNA will be isolated from fecal samples and analyzed by deep-sequencing to determine the composition, abundance, and diversity of gut microbiota.	Baseline, 3 months, 6 months
Change in plasma metabolite concentrations	Metabolite concentrations in plasma samples will be measured by liquid chromatography coupled to mass spectrometry (metabolomics).	Baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Fundació Sant Joan de Déu
• Investigators: Principal Investigator: Carles Lerin, PhD, Fundació Sant Joan de Déu

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: February 27, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Postbiotics
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: PIC-11-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No