An interventional study of Postbiotic ABB C3 and Placebo in Obesity, Childhood and Obesity, Adolescent, sponsored by Fundació Sant Joan de Déu. Active, not recruiting at 1 site in Spain. Open to participants aged 8 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Fundació Sant Joan de Déu · Not applicable, Interventional, and Treatment
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.
1,117 studies on the registry are indexed under Pediatric Obesity; 189 are open to participants now.
This study's planned enrollment of 70 is below the median of 103 across 862 interventional studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →Fundació Sant Joan de Déu is the lead sponsor of 68 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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)
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)
A daily dose of 550 mg of the postbiotic blend ABB C3 in individual sachets for the first 3 months of the study.
A daily dose of 550 mg of the placebo in individual sachets for the first 3 months of the study.
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.
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
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, 6 months
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.
Time frame: 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).
Time frame: Baseline, 3 months, 6 months
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Fundació Sant Joan de Déu