Abdominal ObesityDEMONCT00664729
Diet, Exercise, Metabolism, and Obesity in Older Women
A study testing Caloric Restriction, Caloric Restriction + Low-Intensity aerobic exercise and Caloric Restriction plus High-intensity aerobic exercise in people with Abdominal Obesity and Metabolic Syndrome, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity, Metabolic Syndrome
- What is being tested?
- Caloric Restriction, Caloric Restriction + Low-Intensity aerobic exercise and Caloric Restriction plus High-intensity aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Nov 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Abdominal Obesity, Metabolic Syndrome
- Being tested
- Caloric Restriction, Caloric Restriction + Low-Intensity aerobic exercise, Caloric Restriction plus High-intensity aerobic exercise
- Keywords
- Abdominal, obesity, exercise, intensity, weight loss, women
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome, Obesity, Motor Activity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caloric RestrictionBehavioural
Also called Diet Only
Reduced calorie diet (400 kcal/day deficit)
Caloric Restriction + Low-Intensity aerobic exerciseBehavioural
Also called Diet+Low-Intensity AEX
400 kcal/day deficit plus 3 days/week aerobic exercise at 45-50% maximal aerobic fitness
Caloric Restriction plus High-intensity aerobic exerciseBehavioural
Also called Diet+High-intensity AEX
400 kcal/day deficit and 3 d/week of aerobic exercise at 65-75% maximal fitness
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Caloric Restriction Receives: Behavioral: Caloric Restriction |
| 2 | Experimental | Caloric restriction + Moderate-intensity aerobic exercise Receives: Behavioral: Caloric Restriction + Low-Intensity aerobic exercise |
| 3 | Experimental | Caloric restriction + Vigorous-intensity aerobic exercise Receives: Behavioral: Caloric Restriction plus High-intensity aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal visceral fat volume
Measured: Baseline, follow-up
Secondary outcomes (1)
HDL cholesterol Triglyceride concentrations Glucose tolerance
Measured: Baseline and Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startNov 2002
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Barbara J Nicklas, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664729
- Sponsor's protocol ID
- R01AG020583
- Other IDs
- R01AG020583
- Acronym
- DEMO
- Status last verified
- Jul 2018
- First submitted
- 21 Apr 2008
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
You T, Murphy KM, Lyles MF, Demons JL, Lenchik L, Nicklas BJ. Addition of aerobic exercise to dietary weight loss preferentially reduces abdominal adipocyte size. Int J Obes (Lond). 2006 Aug;30(8):1211-6. doi: 10.1038/sj.ijo.0803245. Epub 2006 Jan 31.
PubMed 16446745You T, Yang R, Lyles MF, Gong D, Nicklas BJ. Abdominal adipose tissue cytokine gene expression: relationship to obesity and metabolic risk factors. Am J Physiol Endocrinol Metab. 2005 Apr;288(4):E741-7. doi: 10.1152/ajpendo.00419.2004. Epub 2004 Nov 23.
PubMed 15562250Wang X, You T, Murphy K, Lyles MF, Nicklas BJ. Addition of Exercise Increases Plasma Adiponectin and Release from Adipose Tissue. Med Sci Sports Exerc. 2015 Nov;47(11):2450-5. doi: 10.1249/MSS.0000000000000670.
PubMed 25811948You T, Disanzo BL, Wang X, Yang R, Gong D. Adipose tissue endocannabinoid system gene expression: depot differences and effects of diet and exercise. Lipids Health Dis. 2011 Oct 28;10:194. doi: 10.1186/1476-511X-10-194.
PubMed 22035053Nicklas BJ, Wang X, You T, Lyles MF, Demons J, Easter L, Berry MJ, Lenchik L, Carr JJ. Effect of exercise intensity on abdominal fat loss during calorie restriction in overweight and obese postmenopausal women: a randomized, controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1043-52. doi: 10.3945/ajcn.2008.26938. Epub 2009 Feb 11.
PubMed 19211823
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet, Exercise, Metabolism, and Obesity in Older Women:DEMO
- ClinicalTrials.gov ID
- NCT00664729
- Acronym / sponsor ID
- DEMO / R01AG020583
- Conditions
- Abdominal Obesity, Metabolic Syndrome
- Keywords
- Abdominal, obesity, exercise, intensity, weight loss, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Nov 2002
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Caloric RestrictionCaloric Restriction |
| 2 | Experimental | Behavioral: Caloric Restriction + Low-Intensity aerobic exerciseCaloric restriction + Moderate-intensity aerobic exercise |
| 3 | Experimental | Behavioral: Caloric Restriction plus High-intensity aerobic exerciseCaloric restriction + Vigorous-intensity aerobic exercise |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caloric RestrictionAlso: Diet OnlyReduced calorie diet (400 kcal/day deficit) | Behavioural | 1 |
| Caloric Restriction + Low-Intensity aerobic exerciseAlso: Diet+Low-Intensity AEX400 kcal/day deficit plus 3 days/week aerobic exercise at 45-50% maximal aerobic fitness | Behavioural | 2 |
| Caloric Restriction plus High-intensity aerobic exerciseAlso: Diet+High-intensity AEX400 kcal/day deficit and 3 d/week of aerobic exercise at 65-75% maximal fitness | Behavioural | 3 |
Primary outcome
Abdominal visceral fat volume
Time frame: Baseline, follow-up
1 secondary outcome
HDL cholesterol Triglyceride concentrations Glucose tolerance
Time frame: Baseline and Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Results publication: PubMed 16446745You T, Murphy KM, Lyles MF, Demons JL, Lenchik L, Nicklas BJ. Addition of aerobic exercise to dietary weight loss preferentially reduces abdominal adipocyte size. Int J Obes (Lond). 2006 Aug;30(8):1211-6. doi: 10.1038/sj.ijo.0803245. Epub 2006 Jan 31.
- Results publication: PubMed 15562250You T, Yang R, Lyles MF, Gong D, Nicklas BJ. Abdominal adipose tissue cytokine gene expression: relationship to obesity and metabolic risk factors. Am J Physiol Endocrinol Metab. 2005 Apr;288(4):E741-7. doi: 10.1152/ajpendo.00419.2004. Epub 2004 Nov 23.
- Derived from this study: PubMed 25811948Wang X, You T, Murphy K, Lyles MF, Nicklas BJ. Addition of Exercise Increases Plasma Adiponectin and Release from Adipose Tissue. Med Sci Sports Exerc. 2015 Nov;47(11):2450-5. doi: 10.1249/MSS.0000000000000670.
- Derived from this study: PubMed 22035053You T, Disanzo BL, Wang X, Yang R, Gong D. Adipose tissue endocannabinoid system gene expression: depot differences and effects of diet and exercise. Lipids Health Dis. 2011 Oct 28;10:194. doi: 10.1186/1476-511X-10-194.
- Derived from this study: PubMed 19211823Nicklas BJ, Wang X, You T, Lyles MF, Demons J, Easter L, Berry MJ, Lenchik L, Carr JJ. Effect of exercise intensity on abdominal fat loss during calorie restriction in overweight and obese postmenopausal women: a randomized, controlled trial. Am J Clin Nutr. 2009 Apr;89(4):1043-52. doi: 10.3945/ajcn.2008.26938. Epub 2009 Feb 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J Nicklas, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caloric Restriction, Caloric Restriction + Low-Intensity aerobic exercise and Caloric Restriction plus High-intensity aerobic exercise in people with Abdominal Obesity and Metabolic Syndrome, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal visceral fat volume (time frame: Baseline, follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664729, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.