Diet, Exercise, Metabolism, and Obesity in Older Women
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 50 - 70 |
| Updated: | 8/3/2018 |
| Start Date: | November 2002 |
| End Date: | November 2008 |
Diet, Exercise, Metabolism, and Obesity in Older Women:DEMO
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.
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.
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.
The diet intervention will consist of monthly meetings with a registered dietitian along with
consuming a hypocaloric diet provided by the GCRC metabolic kitchen. Subjects will be asked
to pick up their food three times a week. Two meals per day will be provided. In addition, a
calcium supplement (1000mg) will be provided. Subjects will be required to keep a diary of
other foods consumed including the calcium supplement. The diets will be composed of 50-60%
carbohydrate, 15-20% protein, and 25-30% fat with adequate amounts of essential nutrients.
The number of calories given to each subject will be estimated from energy expenditure
estimates in combination with an activity factor. The diet only group will be provided with
an approximate 400 kcal/day energy deficit diet, while both exercise groups will be provided
with an approximate 340 kcal/day energy deficit diet. Menus and specific food choices will be
determined by GCRC dietitians in consultation with each research subject.
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.
The diet intervention will consist of monthly meetings with a registered dietitian along with
consuming a hypocaloric diet provided by the GCRC metabolic kitchen. Subjects will be asked
to pick up their food three times a week. Two meals per day will be provided. In addition, a
calcium supplement (1000mg) will be provided. Subjects will be required to keep a diary of
other foods consumed including the calcium supplement. The diets will be composed of 50-60%
carbohydrate, 15-20% protein, and 25-30% fat with adequate amounts of essential nutrients.
The number of calories given to each subject will be estimated from energy expenditure
estimates in combination with an activity factor. The diet only group will be provided with
an approximate 400 kcal/day energy deficit diet, while both exercise groups will be provided
with an approximate 340 kcal/day energy deficit diet. Menus and specific food choices will be
determined by GCRC dietitians in consultation with each research subject.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
1
site
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
336-716-2011
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