Calorie Restriction and Changes in Body Composition, Disease, Function, and Quality of Life in Older Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- Change in Abdominal Fat Mass
研究概览
简要总结
The investigators want to determine if the benefits of weight loss outweigh the potential risk in a group of older adults. The investigators will test the hypothesis that changes in diet composition alone or in conjunction with weight loss will have a significant effect on fat stores, and as a result, improve cardiometabolic risk factors and functional status in adults 65 and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 65 years of age
- •BMI 27 - 42 kg/m2 - at increased health risk (taking at least 1 medication for hypertension, hyperlipidemia, or type 2 diabetes)
排除标准
- •difficulties chewing or swallowing food
- •digestive diseases that may affect the ability to follow a high fiber diet
- •cognitive impairment
- •depression
- •recent weight change (+/- 10 lbs in the last 12 months)
- •poorly controlled blood pressure
- •history of non-skin cancer in last 5 years
- •cardiovascular disease event in past 6 months or severe pulmonary disease or renal failure
- •major liver dysfunction
- •current smoker or quit less than months prior
- •history of prior surgical procedures for weight control or liposuction
- •use of estrogen or testosterone replacement therapy
- •current use of insulin or sulfonylurea agents
- •current use of corticosteroids > 5 days/month on average
- •current use of medications for treatment of psychosis or manic-depressive illness
- •use of weight-loss medications in previous 3 months
- •dependence on others for food procurement or preparation
- •ischemic changes on exercise treadmill test
研究组 & 干预措施
Weight Loss
Participants receive Exercise and Reduced Calorie Diet Interventions
干预措施: Exercise (Behavioral)
Weight Loss
Participants receive Exercise and Reduced Calorie Diet Interventions
干预措施: Reduced Calorie Diet (Behavioral)
Control
Participants receive Exercise Intervention
干预措施: Exercise (Behavioral)
Weight Maintenance
Participants receive Exercise and a Weight Maintenance Diet Interventions
干预措施: Exercise (Behavioral)
Weight Maintenance
Participants receive Exercise and a Weight Maintenance Diet Interventions
干预措施: Weight Maintenance Diet (Behavioral)
结局指标
主要结局
Change in Abdominal Fat Mass
时间窗: Baseline to 1 year
Visceral adipose tissue (cm3) by MRI. Change is calculated as value at baseline minus value at 1 year
次要结局
- Cardiometabolic Risk Factors(Baseline to 1 year)
- Weight Change/Maintenance(Baseline to 1 year)
研究者
Jamy Ard, MD
Associate Professor
University of Alabama at Birmingham