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

This study has been completed.
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: August 15, 2014
Last verified: August 2014
  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
Study Completion Date: August 2014
Primary Completion Date: March 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Western Human Nutrition Center, University of California Davis
Davis, California, United States, 95616
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: August 15, 2014
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 October 01, 2014