Supplements for Controlling Resistance to Insulin
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Body Mass Index
研究概览
简要总结
The purpose of this study is to evaluate the effects of a combination of hydroxcycitrate (HCA) and niacin-bound chromium, in conjunction with nutrition education, over a twelve week period. Participants will be evaluated with regard to BMI, percent body fat, insulin activity, and hunger.
详细描述
The prevalence of obesity among youth has increased dramatically in recent years. Parallel to the increased rates of pediatric obesity, overweight children present clinically with adiposity related comorbidities such as insulin resistance and type 2 diabetes. The prevailing recommendations for overweight youth are to increase physical activity levels and limit energy intake in order to improve body composition. Currently there is little empirical evidence to support the efficacy of these recommendations. Alternatively, evidence in adults suggests that nutritional supplementation with (-) hydroxycitric acid (HCA), an organic acid found naturally in citrus fruits, and chromium may lead to favorable changes in body composition and improve glucose regulation. To date, these issues have not been tested in youth. Therefore, the purpose of the present investigation is to examine the effects of a nutritional education program combined with either HCA + chromium or placebo on measures of body composition and glucose regulation in overweight adolescents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects will be between 13 and 17 years of age
- •Overweight
- •All subjects will be overweight as defined by an age & sex-specific body mass index ≥ 85th percentile based on CDC BMI growth charts [US Department of Health and Human Services, 2000], calculated by Epi Info Software, version 3.3.
排除标准
- •Presently taking any prescribed medication(s) or diagnosed with any syndrome or disease that could influence dietary intake, body composition and fat distribution, or insulin action or secretion.
- •Previously diagnosed with any major illness since birth (e.g. sever intrauterine growth retardation, chronic birth asphyxia, cancer).
- •Children with type 1 and/or type 2 diabetes will be excluded are referred to a physician.
- •Currently involved with any dietary, exercise, or weight loss program or have been in the 6 months prior to participation.
- •Unexplained weight loss or gain in the prior six months.
- •Oral contraception use in sexually active females
- •Children who live further than 20 miles away from the USC Health Science Campus (HSC).
研究组 & 干预措施
1 - nutrition education plus active supplement
nutrition education plus active supplement
干预措施: nutrition education plus active supplement (Drug)
2 - nutrition education plus inactive supplement
nutrition education plus inactive supplement
干预措施: nutrition education plus inactive supplement (Drug)
结局指标
主要结局
Body Mass Index
时间窗: measured at baseline and 12 weeks
Change in Body Mass Index measurement at baseline and 12 weeks
次要结局
- Insulin Activity(Measured at baseline and 12 weeks)
- Percent Body Fat(Measured at baseline and 12 weeks)
- Hunger(Measured at baseline and 12 weeks)
研究者
Michael I. Goran
Professor
University of Southern California