The Hormonal and Behavioral Impact of Eating Breakfast

Completed

• Conditions: Eating Behavior

• Registration Number: NCT01427556
• Lead Sponsor: USDA, Western Human Nutrition Research Center

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-09-01
• Primary Completion: 2014-03
• Status Verified: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-15
• Last Update Posted: 2014-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Food Intake Behavior	week 6	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

Name	Time	Method
Markers of nutrient metabolism	week 6	Blood glucose, insulin, lipids, and metabolic hormones will be measured.

Trial Locations

Locations (1)

Western Human Nutrition Center, University of California Davis; 🇺🇸 Davis, California, United States