Effect of Glucomannan Supplementation on Body Weight in Overweight and Obese Children: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- BMI-for-age z-score difference
研究概览
简要总结
Glucomannan (GNN), a water-soluble dietary fiber derived from the plant Amorphophallus konjac, is marketed for weight reduction. The exact mechanisms by which GNN might exert its actions are unclear. Nonetheless, it has been shown that GNN slows gastric emptying by forming a viscous gel of large volume, which increases the feeling of satiety. Current evidence on the effectiveness of GNN for weight reduction is sparse, and well-designed trials performed in children are needed to assess the efficacy of this modality. We aim to systematically evaluate the efficacy of GNN consumption for the management of overweight and obesity in children.
详细描述
Methods and analysis
Children aged 6 to 17 years with overweight and obesity (based on the WHO growth criteria) will be randomly assigned to receive GNN or placebo (maltodextrin) (both at a dose of 3 g/day) for 3 months and will be followed up for 3 months. Prior to the intervention, all children will receive dietetic advice, and they will be encouraged to engage in physical activity. The primary outcome measure will be the BMI-for-age z-score difference between the groups at the end of the intervention.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 6-17 years;
- •overweight or obesity based on the WHO (World Health Organization) growth charts/references (>+1 standard deviation [SD] or >+2 SD, respectively)
排除标准
- •drug therapy for a chronic disease (including drugs that influence appetite or body weight);
- •type 1 or 2 diabetes;
- •history of surgical treatment of obesity;
- •participation in another program for treating obesity during the project and/or 3 months prior to recruitment;
- •secondary causes of obesity;
- •pregnancy.
研究组 & 干预措施
Glucomannan
Glucomannan orally, 3g/day (in three divided doses), for 12 weeks
干预措施: Glucomannan (Dietary Supplement)
Maltodextrin
Maltodextrin orally, 3g/day (in three divided doses), for 12 weeks
干预措施: Maltodextrin (Dietary Supplement)
结局指标
主要结局
BMI-for-age z-score difference
时间窗: 0-12 weeks
Baseline versus end of the intervention
次要结局
- BMI-for-age z-score difference(0-24 weeks)
- Energy intake (kJ/d)(At baseline and at week 12, week 24.)
- Body composition(0-13 weeks)
- Proportion of participants with dyslipidemia(At baseline, 12 weeks and 24 weeks)
- Physical activity(at baseline and at week 12)
- Adverse events(0-12 weeks)
- Proportion of participants with impaired fasting plasma glucose (FPG)(At baseline, 12 weeks and 24 weeks)
- Blood pressure (systolic and diastolic)(Baseline, week 12, 24 weeks.)