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

U

USDA, Western Human Nutrition Research Center

Status

Completed

Conditions

Eating Behavior

Study type

Observational

Funder types

Other U.S. Federal agency

Identifiers

NCT01427556
WHNRC 213098-1

Details and patient eligibility

About

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.

Full description

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

Enrollment

120 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Breakfast Eaters
Description:
Women who self-report eating breakfast regularly.
Non-Breakfast Eaters
Description:
Women who self-report skipping breakfast regularly.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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