Impact of Jump Start Nutrition Program on Weight Loss and Associated Measures of Health in Overweight and Obese Men and Women
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Body Composition
研究概览
简要总结
The purpose of the proposed study is to evaluate the impact of the Jump Start program to facilitate weight loss in a sample of overweight and obese men and women. The study will not only evaluate weight loss and changes in body-shape but will also assess the type of weight lost (fat vs. lean mass) and other health measures affected by obesity including lipids, glucose, insulin, resting heart rate and blood pressure, and perceived wellness. This study will contribute to the general weight loss literature by providing evidence for or against the use of a meal replacement centered one-week weight loss program to yield weight loss and other health-specific benefits. The hypothesis is that the Jump Start program will result in an average 3-5 pound weight loss, as well as improvements in bloodborne markers of health, from day 1 to day 8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 28-39.9 kg/m2
- •can fast >10 hours
- •maintain existing exercise regiment during study
排除标准
- •Weight greater than 500 lbs
- •Type I or II diabetic
- •liver disease
- •tobacco user
- •adversity to fiber or protein supplement
- •taking weight loss dietary supplements or adhering to any weight loss plan in the month prior to and during participation in the study
- •taking a multi-vitamin or pro-biotic, or if they were not recommended by a doctor, willing to stop for 4 weeks prior to the study.
- •consumption of alcohol or caffeine within 24 hours of each testing visit
- •strenuous exercise during the 24 hours period before each testing visit
- •self-reported active infection or illness of any kind
- •pregnant or lactating
研究组 & 干预措施
Jump Start Program
The intervention consists of following the Jump Start plan for 7 days
干预措施: Jump Start Nutritional Program (Dietary Supplement)
结局指标
主要结局
Body Composition
时间窗: Day 8
Changes in body composition as measured by dual-energy X-ray absorptiometry from baseline
Lipids Panel
时间窗: Day 8
Changes in lipids panel from baseline
Glucose
时间窗: Day 8
Changes in glucose from baseline
Insulin
时间窗: Day 8
Changes in insulin from baseline
Body Weight
时间窗: Day 8
Changes in body weight from baseline
Body Mass Index
时间窗: Day 8
Changes in body mass index from baseline
Resting Blood pressure
时间窗: Day 8
Changes in resting blood pressure from baseline
Resting Heart Rate
时间窗: Day 8
Changes in resting heart rate from baseline
Subjects' perceived wellness
时间窗: Day 8
Changes in subjects perceived wellness from baseline using a visual analog scale from 0 to 10 with 0 being very low and 10 being extremely high
Hip Circumference
时间窗: Day 8
Changes in hip circumference from baseline
Waist Circumference
时间窗: Day 8
Changes in waist circumference from baseline
Physical Appearance
时间窗: Day 8
Changes in physical appearance of trunk region from bottom of neck to knee region
次要结局
- Diet(Day 8)