USDA Behavior, Motivation & Nutrition Study

NCT ID: NCT00838409

Last Updated: 2011-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Body Weight

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

42 Years

Maximum Eligible Age

52 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Laugero, PhD

Role: PRINCIPAL_INVESTIGATOR

USDA, ARS, Western Human Nutrition Research Center

Locations

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USDA, ARS, Western Human Nutrition Research Center

Davis, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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WHNRC003

Identifier Type: -

Identifier Source: org_study_id

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