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NCT Number: NCT06309121

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Obesity, Childhood Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Adolescent Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sant Joan de Déu

Barcelona, 08950, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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.

  2. 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. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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.

  9. 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.

Other outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Fundació Sant Joan de Déu

Other

Registry information

Acronym: PostOb

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 13, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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