The Effect of the Oligofructose Supplementation on Body Weight in Overweight and Obese Children: a Randomized, Double Blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- BMI z-score difference
研究概览
简要总结
This study is designed to assess the effect of oligofructose administration for 12 weeks on Body Mass Index (BMI) of overweight and obese children.
详细描述
The prevalence of childhood overweight and obesity is reaching epidemic proportions. There have been no effective methods for preventing or treating obesity in childhood so far prompting interest in new interventions. One potential option for obesity prevention is the use of the prebiotic oligofructose. Data from research on rodents shows that a high-fat diet enriched with oligofructose causes a decrease in energy intake, less weight gain and a lower level of triglycerides . A similar effect has been observed in healthy adults. Available evidence suggests that the addition of oligofructose to the diets of overweight or obese adults may increase satiety and thus reduce energy intake. Currently, there are no data on the effect of oligofructose in overweight and obese children.
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
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 7 to 18 years
- •BMI > 85 percentile
- •Signed informed consent
排除标准
- •Overweight / obesity secondary to genetic syndromes and/or endocrine diseases
结局指标
主要结局
BMI z-score difference
时间窗: after 12 weeks of the intervention
次要结局
- Mean BMI z-score(after 12 and 24 weeks of the intervention)
- Percentage of the children with dyslipidemias(after 12 weeks of the intervention)
- Percentage of the children with hypertension(after 12 weeks of the intervention)
- Adverse effects(during intervention)
- Self-reported energy intake (3-day diet record)(after 12 weeks of the intervention)
- Percentage of weight reduction(after 12 weeks of the intervention)
- Percentage of children with BMI-for-age > 85percentile(after 12 and 24 weeks of the intervention)
- Percentage of the children with abnormal fasting glucose(after 12 weeks of the intervention)
- BMI z-score difference(after 24 weeks of the intervention)
- Difference in total body fat measured by Dual-Energy X-ray Absorptiometry (DEXA)(after 12 weeks of the intervention)
研究者
Hanna Szajewska
Professor
Medical University of Warsaw