Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents
- Conditions
- Obesity, ChildhoodObesity, Adolescent
- Interventions
- Dietary Supplement: Postbiotic ABB C3Dietary Supplement: PlaceboDietary Supplement: Follow-up Postbiotic ABB C3 (Optional)
- Registration Number
- NCT06309121
- Lead Sponsor
- Fundació Sant Joan de Déu
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
- Age between 8- and 18-year-old
- Obesity (BMI-SDS > 2)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active control 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 placebo for these 3 months, then given the option to receive a daily dose of probiotic ABB C3 for 3 more months. Treatment Postbiotic ABB C3 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. Active control Placebo 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. Treatment 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.
- Primary Outcome Measures
Name Time Method Incidence of Adverse Events 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.
Change in blood glycated hemoglobin (HbA1c) levels 3 months Blood tests will be performed at baseline and 3 months and HbA1c (%) levels quantified.
Change in adiposity (% fat body mass) 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
- Secondary Outcome Measures
Name Time Method Change in adiposity (% fat body mass) 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.
Change in blood glycated hemoglobin (HbA1c) levels Baseline, 6 months Blood tests will be performed at baseline and 6 months and HbA1c (%) levels quantified. Differences between time-points will be assessed.
Change in insulin sensitivity 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
Change in lipid profile (triglycerides, cholesterol) Baseline, 3 months, 6 months The lipid profile will be determined by blood test and differences between time-points will be assessed
Change in BMI z-score 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.
Change in body composition 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.
Change in blood pressure 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
Change in Beck Depression Inventory-II (BDI-2) 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.
Change in Beck Anxiety Inventory-II (BAI-2) 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.
Trial Locations
- Locations (1)
Hospital Sant Joan de Déu
🇪🇸Barcelona, Spain