Diet, Exercise, Metabolism, and Obesity in Older Women (DEMO)

This study has been completed.
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00664729
First received: April 21, 2008
Last updated: January 12, 2010
Last verified: April 2008
  Purpose

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.


Condition Intervention
Abdominal Obesity
Metabolic Syndrome
Behavioral: Caloric Restriction
Behavioral: Caloric Restriction + Low-Intensity aerobic exercise
Behavioral: Caloric Restriction plus High-intensity aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Diet, Exercise, Metabolism, and Obesity in Older Women:DEMO

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Abdominal visceral fat volume [ Time Frame: Baseline, follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HDL cholesterol Triglyceride concentrations Glucose tolerance [ Time Frame: Baseline and Follow-up ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: November 2002
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Caloric Restriction
Behavioral: Caloric Restriction
Reduced calorie diet (400 kcal/day deficit)
Other Name: Diet Only
Experimental: 2
Caloric restriction + Moderate-intensity aerobic exercise
Behavioral: Caloric Restriction + Low-Intensity aerobic exercise
400 kcal/day deficit plus 3 days/week aerobic exercise at 45-50% maximal aerobic fitness
Other Name: Diet+Low-Intensity AEX
Experimental: 3
Caloric restriction + Vigorous-intensity aerobic exercise
Behavioral: Caloric Restriction plus High-intensity aerobic exercise
400 kcal/day deficit and 3 d/week of aerobic exercise at 65-75% maximal fitness
Other Name: Diet+High-intensity AEX

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664729

Locations
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Barbara J Nicklas, PhD Wake Forest School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barbara J Nicklas, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00664729     History of Changes
Other Study ID Numbers: R01 AG020583
Study First Received: April 21, 2008
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

Keywords provided by Wake Forest School of Medicine:
Abdominal
obesity
exercise
intensity
weight loss
women

Additional relevant MeSH terms:
Obesity
Metabolic Syndrome X
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014