USDA Behavior, Motivation & Nutrition Study

Completed

• Conditions: Body Weight

• Registration Number: NCT00838409
• Lead Sponsor: USDA, Western Human Nutrition Research Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-05
• Study First Posted: 2009-02-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-13
• Last Update Posted: 2011-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between metabolic measures and health-related behaviors in normal weight and overweight/obese perimenopausal women.	3 months

Trial Locations

Locations (1)

USDA, ARS, Western Human Nutrition Research Center; 🇺🇸 Davis, California, United States