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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
  Purpose

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.


Condition
Eating Behavior

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: CCRC: The Hormonal and Behavioral Impact of Eating Breakfast

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

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Markers of nutrient metabolism [ Time Frame: week 6 ] [ Designated as safety issue: No ]
    Blood glucose, insulin, lipids, and metabolic hormones will be measured.


Biospecimen Retention:   Samples With DNA

Serum and saliva samples will be retained.


Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breakfast Eaters
Women who self-report eating breakfast regularly.
Non-Breakfast Eaters
Women who self-report skipping breakfast regularly.

Detailed Description:

Healthy women will be studies in a cross-sectional fashion to examine the metabolic, hormonal and behavioral factors associated with breakfast skipping.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

One hundred and twenty pre-menopausal women, aged 20 to 45y, who report eating breakfast regularly or skipping breakfast regularly.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427556

Contacts
Contact: Mary Ellen Rivera (530) 754-5248 maryellen.rivera@ars.usda.gov

Locations
United States, California
Western Human Nutrition Center, University of California Davis Recruiting
Davis, California, United States, 95616
Contact: Ellen Bonnel, PhD     530-752-4184     ellen.bonnel@ars.usda.gov    
Principal Investigator: Nancy Keim, PhD            
Sponsors and Collaborators
USDA, Western Human Nutrition Research Center
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: Nancy Keim, PhD WHNRC, ARS, University of California Davis
  More Information

No publications provided

Responsible Party: USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT01427556     History of Changes
Other Study ID Numbers: WHNRC 213098-1
Study First Received: August 30, 2011
Last Updated: March 21, 2013
Health Authority: United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:
Food intake
Breakfast eating

ClinicalTrials.gov processed this record on May 23, 2013