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The Hormonal and Behavioral Impact of Eating Breakfast (FL-74)

This study is currently recruiting participants.
Verified March 2013 by USDA, Western Human Nutrition Research Center
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01427556
First received: August 30, 2011
Last updated: March 21, 2013
Last verified: March 2013
History of Changes

August 30, 2011
March 21, 2013
August 2009
September 2013   (final data collection date for primary outcome measure)
Food Intake Behavior [ Time Frame: week 6 ] [ Designated as safety issue: No ]
The goal is to explore the relationship between food intake behavior and the hypothalamic-pituitary axis (HPA) in a group of women who regularly skip breakfast and in another group of women who regularly eat breakfast.
Same as current
Complete list of historical versions of study NCT01427556 on ClinicalTrials.gov Archive Site
Markers of nutrient metabolism [ Time Frame: week 6 ] [ Designated as safety issue: No ]
Blood glucose, insulin, lipids, and metabolic hormones will be measured.
Same as current
Not Provided
Not Provided
 
The Hormonal and Behavioral Impact of Eating Breakfast
CCRC: The Hormonal and Behavioral Impact of Eating Breakfast

This study is exploring the relationship between food intake behavior and the hypothalamic-pituitary axis (HPA) in women who regularly skip breakfast compared to women who regularly eat breakfast.

Healthy women will be studies in a cross-sectional fashion to examine the metabolic, hormonal and behavioral factors associated with breakfast skipping.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum and saliva samples will be retained.
Non-Probability Sample

One hundred and twenty pre-menopausal women, aged 20 to 45y, who report eating breakfast regularly or skipping breakfast regularly.
Eating Behavior
Not Provided
  • Breakfast Eaters
    Women who self-report eating breakfast regularly.
  • Non-Breakfast Eaters
    Women who self-report skipping breakfast regularly.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pre-menopausal women (as determined by self-report of menstrual history and confirmation with plasma FSH)
  • 20 to 45 years old,
  • BMI less than 40 kg/m2
  • Stable body weight (fluctuation of less than ± 3%) for past 3 months.
  • Breakfast eaters: defined as eating at least 15% of total daily energy intake at a meal between 0400-1000 h at least 6 days/week.
  • Breakfast skippers: defined as eating no foods or beverages between 0400-1000h at least 4 days/week or only taking beverages (no solid food) containing less than ~100 kcal.

Exclusion Criteria:

  • Erratic/intermittent breakfast eating
  • Currently pregnant or lactating
  • Shift workers/diagnosed sleep disorders
  • Use of tobacco products
  • Use of non-prescription drugs/hormone replacement/steroid-based medications
  • Diagnosed endocrine, metabolic, or digestive disorder
  • Hemoglobin <11 g/dl
  • Plasma Glucose >120 mg/dl
Female
20 Years to 45 Years
Yes
Contact: Mary Ellen Rivera (530) 754-5248 maryellen.rivera@ars.usda.gov
United States
 
NCT01427556
WHNRC 213098-1
No
USDA, Western Human Nutrition Research Center
USDA, Western Human Nutrition Research Center
USDA Beltsville Human Nutrition Research Center
Principal Investigator: Nancy Keim, PhD WHNRC, ARS, University of California Davis
USDA, Western Human Nutrition Research Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP