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

March 19, 2026 updated by: Fundació Sant Joan de Déu
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marta Ramon Krauel, MD, PhD
  • Phone Number: 71263 (+34) 932804000
  • Email: marta.ramon@sjd.es

Study Locations

  • Spain
    • Barcelona
      • Barcelona, Barcelona, Spain, 08950
        • Hospital Sant Joan de Déu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events
Time Frame: Baseline, 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.
Baseline, 1.5 months, 3 months
Change in adiposity (% fat body mass)
Time Frame: 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
3 months
Change in blood glycated hemoglobin (HbA1c) levels
Time Frame: 3 months
Blood tests will be performed at baseline and 3 months and HbA1c (%) levels quantified.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in adiposity (% fat body mass)
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 6 months
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
Time Frame: Baseline, 1.5 months, 3 months, 6 months
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
Time Frame: Baseline, 1.5 months, 3 months, 6 months
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
Time Frame: Baseline, 3 months, 6 months
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)
Time Frame: Baseline, 3 months, 6 months
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
Time Frame: Baseline, 3 months, 6 months
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)
Time Frame: Baseline, 3 months, 6 months
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)
Time Frame: Baseline, 3 months, 6 months
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in gut microbial abundance and diversity
Time Frame: Baseline, 3 months, 6 months
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
Time Frame: Baseline, 3 months, 6 months
Metabolite concentrations in plasma samples will be measured by liquid chromatography coupled to mass spectrometry (metabolomics).
Baseline, 3 months, 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundació Sant Joan de Déu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carles Lerin, PhD, Fundació Sant Joan de Déu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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