NCT01011491已完成不适用
Efficacy of Medifast's 5 & 1 Program Compared to a Food-based Diet After a Period of Weight Loss and Weight Maintenance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Weight change (in kilograms) from week 0
研究概览
简要总结
Portion-controlled meal replacements have been shown to be an effective weight control strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the effect of Medifast's 5 & 1 program compared to an food-based diet plan of equal calories on the following indices: weight loss and maintenance of weight loss, satiety during weight loss, changes in biochemical markers of inflammation and oxidative stress following weight loss, and compliance and retention rates.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males and females (age between 18 and 65)
- •Obese (BMI >=30.0 kg/m2 and <50.0 kg/m2)
- •Non-smokers
- •No known food allergies to wheat, gluten, soy or nuts
- •<14 alcoholic beverages per week
- •Willing and able to give informed consent
- •Not currently using appetite-affecting medications (e.g SSRIs, steroids, Ritalin)
- •Not pregnant or lactating
- •Primary care physician's permission for weight loss, normal labs and electrocardiogram (EKG) within past 1 year
排除标准
- •Actively dieting
- •Eating Attitudes Test (EAT) > 30
- •Chronic uncontrolled health problems (not including obesity or diabetes)
- •Pacemaker or other internal electronic medical device
- •Schizophrenia, history of bipolar disorder, current Major Depressive Disorder
- •Dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines)
- •Cognitive impairment severe enough to preclude informed consent
- •Taking weight loss or appetite-suppressant medications
- •Taking appetite affecting medications (e.g. SSRIs, steroids, Ritalin)
- •Food allergies to wheat, gluten, soy, or nuts
- •Pregnant or lactating
结局指标
主要结局
Weight change (in kilograms) from week 0
时间窗: 16 weeks
次要结局
- Satiety using a visual analog scale(16 weeks)
- Change in Inflammation represented by C-reactive protein(16 and 40 weeks)
- Change in Oxidative Stress represented by urine lipid peroxides(16 and 40 weeks)
- Blood Pressure change(16 and 40 weeks)
- Change in Pulse(16 and 40 weeks)
- Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms)(24 weeks)
- Change in percent body fat (a measure representing a change in body composition)(16 and 40 weeks)
- Change in Blood lipids(16 and 40 weeks)
- Change in lean muscle mass (a measure representing change in body composition)(16 and 40 weeks)
- Change in Waist circumference (a measure representing change in body composition)(16 and 40 weeks)
- Change in Visceral Fat Rating (a measure representing change in body composition)(16 and 40 weeks)
研究者
研究点 (2)
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