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Completed

NCT Number: NCT00838409

USDA Behavior, Motivation & Nutrition Study

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.

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Key information

Age range

42 year–52 year

Sex eligibility

Female

Study type

Observational

Primary location

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between metabolic measures and health-related behaviors in normal weight and overweight/obese perimenopausal women.

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 6, 2009
Registry last updated
Sep 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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