The Hormonal and Behavioral Impact of Eating Breakfast

Eating Behavior Clinical Trial

— FL-74  

Official title:

CCRC: The Hormonal and Behavioral Impact of Eating Breakfast

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427556
• Other study ID #: WHNRC 213098-1
• Status: Completed
• Phase: N/A
• First received: August 30, 2011
• Last updated: August 15, 2014
• Start date: August 2009
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: USDA, Western Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Eating Behavior

Locations

Country	Name	City	State
United States	Western Human Nutrition Center, University of California Davis	Davis	California

Sponsors (2)

Lead Sponsor	Collaborator
USDA, Western Human Nutrition Research Center	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Food Intake Behavior	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.	week 6	No
Secondary	Markers of nutrient metabolism	Blood glucose, insulin, lipids, and metabolic hormones will be measured.	week 6	No