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临床试验/NCT00664729
NCT00664729已完成不适用

Diet, Exercise, Metabolism, and Obesity in Older Women:DEMO

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2002年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
112
试验地点
2
主要终点
Abdominal visceral fat volume

研究概览

简要总结

Reductions in fat oxidation and resting metabolic rate (RMR) are associated with normal aging and are accelerated with menopause. As a result, postmenopausal women have an increased risk of abdominal obesity and ultimately the metabolic complications that lead to the insulin resistance syndrome and its associated risks (hyperlipidemia, type 2 diabetes, and coronary heart disease). Thus, there is a need to determine the most successful treatment to reduce visceral obesity in postmenopausal women. The purpose of this study is to determine if dietary-induced weight loss alone and/or weight loss combined with exercise at low and high- intensities differentially affect the reduction in visceral adipose tissue in postmenopausal women with abdominal obesity.

详细描述

Design Overview:

This study's protocol will last approximately 18 months. Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of three 5-month treatments (Phase 3): diet and high-intensity exercise, diet and low-intensity exercise, or diet only. In the Maintenance Phase, subjects will return for visits at 6 & 12 months following the completion of their 5 month intervention.

Interventions:

All treatment groups will experience the same total weekly caloric deficit (-2800 kcal/wk), but will derive this deficit by different reductions in dietary intake and exercise energy expenditure. The weekly caloric deficit will be accomplished as follows: 1) the diet alone group will reduce dietary intake by ~2800 kcal/week (~400 kcal/day); 2) both exercise groups will expend ~400 kcal/wk in exercise energy expenditure and will reduce dietary intake by ~2400 kcal/wk (~340 kcal/day) to achieve the 2800 kcal/wk deficit.

The exercise will take place in an exercise facility at the Geriatric Research Center on the campus of the Wake Forest University/Baptist Medical Center. Two study personnel, including at least one trained technician, will supervise all exercise sessions. Emergency equipment will be kept on site during exercise sessions. Blood pressure and heart rate will be measured and recorded before each exercise session and participants will warm-up by walking for 3-5 min at a slow pace. Women will use the treadmill to exercise at an intensity of 45-50% (low-intensity AEX) or 70-75% (high-intensity AEX) of VO2max. Both groups will exercise 3 d/wk and duration of exercise will progress from 10-15 min the 1st week to 55 min by the end of the 6th week and thereafter for the low-intensity AEX group. The duration of exercise for the high-intensity AEX group will progress from 10-15 min the 1st week to 30 min by the end of the 6th week and thereafter. Injuries are minimized by a feasible progression of exercise duration as well as careful monitoring of proper footwear and stretching exercises.

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
50 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Currently 50 - 70 years of age (at screening)
  • Post-menopausal at least 1 year
  • Waist diameter of at least 34"
  • Able to attend exercise classes 3 times per week
  • BMI between 25 & 40 kg/m2
  • MMSE > 25

排除标准

  • Exercises regularly (ie- more than twice a week for more than 15 minutes per session)?
  • Uncontrolled diabetes mellitus or insulin-controlled diabetes?
  • Does not drive and does not have a reliable way to pick up meals once a week
  • Cancer in past 5 years except skin cancer
  • Unwilling or unable to eat prepared foods (non-compliant during test week)
  • Unwilling or unable to record food intake accurately
  • Self-reported weight loss or gain >5% in past 6 months
  • Smoking within past year, or use of tobacco or nicotine product
  • Coronary artery disease, liver disease, renal disease, or other systemic disorders
  • Pulmonary disease
  • Current use of thiazide diuretics, beta blockers or steroids
  • Current use of more than one anti-hypertensive medication
  • Current use of anti-depressants or hormone replacement therapy
  • Gross physical impairment
  • Blindness or retinopathy
  • Triglyceride level >400 mg/dl
  • Anemia (Hct < 37%)
  • Contraindication to exercise by ECG or GXT

研究组 & 干预措施

2

Experimental

Caloric restriction + Moderate-intensity aerobic exercise

干预措施: Caloric Restriction + Low-Intensity aerobic exercise (Behavioral)

3

Experimental

Caloric restriction + Vigorous-intensity aerobic exercise

干预措施: Caloric Restriction plus High-intensity aerobic exercise (Behavioral)

1

Active Comparator

Caloric Restriction

干预措施: Caloric Restriction (Behavioral)

结局指标

主要结局

Abdominal visceral fat volume

时间窗: Baseline, follow-up

次要结局

  • HDL cholesterol Triglyceride concentrations Glucose tolerance(Baseline and Follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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