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USDA Behavior, Motivation & Nutrition Study

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ClinicalTrials.gov Identifier: NCT00838409
Recruitment Status : Completed
First Posted : February 6, 2009
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Body Weight

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 Type : Observational
Actual Enrollment : 40 participants
Time Perspective: Cross-Sectional
Official Title: Examination of Metabolic Determinants of Behavior and Motivation in Obesity: Implication to the Development of New Strategies for Achieving Body Weight Health
Study Start Date : May 2008
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Group/Cohort
1



Primary Outcome Measures :
  1. Correlation between metabolic measures and health-related behaviors in normal weight and overweight/obese perimenopausal women. [ Time Frame: 3 months ]

Biospecimen Retention:   Samples With DNA
Blood and saliva samples will be kept for future research purposes.


Information from the National Library of Medicine

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Ages Eligible for Study:   42 Years to 52 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00838409


Locations
United States, California
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States, 95616
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
Investigators
Principal Investigator: Kevin Laugero, PhD USDA, ARS, Western Human Nutrition Research Center

Additional Information:
Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00838409     History of Changes
Other Study ID Numbers: WHNRC003
First Posted: February 6, 2009    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms