Diet, Exercise, Metabolism, and Obesity in Older Women
DEMO
1 other identifier
interventional
112
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
April 21, 2008
CompletedFirst Posted
Study publicly available on registry
April 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedAugust 1, 2018
July 1, 2018
6 years
April 21, 2008
July 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abdominal visceral fat volume
Baseline, follow-up
Secondary Outcomes (1)
HDL cholesterol Triglyceride concentrations Glucose tolerance
Baseline and Follow-up
Study Arms (3)
1
ACTIVE COMPARATORCaloric Restriction
2
EXPERIMENTALCaloric restriction + Moderate-intensity aerobic exercise
3
EXPERIMENTALCaloric restriction + Vigorous-intensity aerobic exercise
Interventions
400 kcal/day deficit plus 3 days/week aerobic exercise at 45-50% maximal aerobic fitness
400 kcal/day deficit and 3 d/week of aerobic exercise at 65-75% maximal fitness
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Related Publications (5)
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.
PMID: 16446745RESULTYou 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.
PMID: 15562250RESULTWang 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.
PMID: 25811948DERIVEDYou 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.
PMID: 22035053DERIVEDNicklas 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.
PMID: 19211823DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Barbara J Nicklas, PhD
Wake Forest University Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2008
First Posted
April 23, 2008
Study Start
November 1, 2002
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
August 1, 2018
Record last verified: 2018-07