Effects of the Postbiotic Blend ABB C3 on Adiposity and Glucose Metabolism in Children and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8- and 18-year-old
- •Obesity (BMI-SDS > 2)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Placebo (Dietary Supplement)
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.
干预措施: Follow-up Postbiotic ABB C3 (Optional) (Dietary Supplement)
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.
干预措施: Postbiotic ABB C3 (Dietary Supplement)
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.
干预措施: Follow-up Postbiotic ABB C3 (Optional) (Dietary Supplement)
结局指标
主要结局
Incidence of Adverse Events
时间窗: 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
时间窗: 3 months
Blood tests will be performed at baseline and 3 months and HbA1c (%) levels quantified.
Change in adiposity (% fat body mass)
时间窗: 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
次要结局
- Change in adiposity (% fat body mass)(Baseline, 6 months)
- Change in blood glycated hemoglobin (HbA1c) levels(Baseline, 6 months)
- Change in insulin sensitivity(Baseline, 3 months, 6 months)
- Change in lipid profile (triglycerides, cholesterol)(Baseline, 3 months, 6 months)
- Change in BMI z-score(Baseline, 1.5 months, 3 months, 6 months)
- Change in body composition(Baseline, 1.5 months, 3 months, 6 months)
- Change in blood pressure(Baseline, 3 months, 6 months)
- Change in Beck Depression Inventory-II (BDI-2)(Baseline, 3 months, 6 months)
- Change in Beck Anxiety Inventory-II (BAI-2)(Baseline, 3 months, 6 months)