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NCT00838409 Clinical Trial

USDA Behavior, Motivation & Nutrition Study

Body Weight Clinical Trial

Official title:
Examination of Metabolic Determinants of Behavior and Motivation in Obesity: Implication to the Development of New Strategies for Achieving Body Weight Health

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00838409
Other study ID # WHNRC003
Secondary ID
Status Completed
Phase N/A
First received February 4, 2009
Last updated September 13, 2011
Start date May 2008
Est. completion date June 2011

Study information
Verified date September 2011
Source USDA, Western Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 42 Years to 52 Years
Eligibility 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

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
United States USDA, ARS, Western Human Nutrition Research Center Davis California

Sponsors (1)
Lead Sponsor Collaborator
USDA, Western Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation between metabolic measures and health-related behaviors in normal weight and overweight/obese perimenopausal women. 3 months No
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