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USDA Behavior, Motivation & Nutrition Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00838409
First received: February 4, 2009
Last updated: September 13, 2011
Last verified: September 2011
History of Changes
  Purpose

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
Body Weight

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:
  • Correlation between metabolic measures and health-related behaviors in normal weight and overweight/obese perimenopausal women. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood and saliva samples will be kept for future research purposes.


Enrollment: 40
Study Start Date: May 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

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.

  Eligibility

Ages Eligible for Study:   42 Years to 52 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
USDA, ARS, WHNRC  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT00838409     History of Changes
Other Study ID Numbers: WHNRC003
Study First Received: February 4, 2009
Last Updated: September 13, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013