USDA Behavior, Motivation & Nutrition Study

USDA, Western Human Nutrition Research Center

Status: Completed

Conditions: Body Weight

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT00838409

WHNRC003

Details and patient eligibility

About

This study will be a cross-sectional study. The primary aim of this study is to compare the relationship between neurological function, metabolic measures and health-related behaviors between normal weight and overweight/obese perimenopausal women.

Full description

To examine physiological and behavioral factors that may help determine health in perimenopausal middle age women. Neuroendocrine function will be measured by broad assessment of hypothalamic-pituitary-adrenal (HPA) activity. We will also assess metabolic profiles and behavioral and emotional function. We plan to determine correlations between these measures and nutritional state. Other measures may include insulin, glucose, leptin, IGF-1, triglycerides, free fatty acids, and ghrelin and eating attitudes and physical reactivity.

Enrollment: 40 patients

Sex: Female

Ages: 42 to 52 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body Mass index 18-39.9 kg/m2
• Peri-menopausal status by self-report

Exclusion criteria

• Pregnant
• Plan to become pregnant
• Breastfeeding in the last 6 months
• Multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease
• Menopause confirmed
• Unable to refrain from smoking for five hours (self-report)
• Unable to refrain from consuming alcohol for two days (self-report)
• Weight change > 10 lbs in the preceding 6 months
• Chronic corticosteroid use
• Oral corticosteroids used more than twice in the last 12 months
• Hormonal contraceptives
• Antipsychotic, anti-anxiety and anti-depressant medications
• Beta adrenergic blockers
• Sibutramine, orlistat, phentermine, phendimetrazine, topiramate, zonisamide
• Immunosuppressants
• Amphetamines and other stimulants
• Severe food allergies or intolerances to foods
• Insulin Dependent Diabetes Mellitus

Trial design

40 participants in 1 patient group

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