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Completed

NCT Number: NCT01427556

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.

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Key information

Conditions

Eating Behavior Behavior Behavior, Animal Feeding Behavior

Age range

20 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Western Human Nutrition Center, University of California Davis

Davis, California, 95616, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Food Intake Behavior

    Time frame: 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 outcomes

  1. Markers of nutrient metabolism

    Time frame: week 6

    Blood glucose, insulin, lipids, and metabolic hormones will be measured.

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

  • USDA Beltsville Human Nutrition Research Center

Registry information

Official study title

CCRC: The Hormonal and Behavioral Impact of Eating Breakfast

Acronym: FL-74

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Sep 1, 2011
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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