The Hormonal and Behavioral Impact of Eating Breakfast

NCT ID: NCT01427556

Last Updated: 2014-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2014-08-31

Brief Summary

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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

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

Conditions

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Eating Behavior

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Breakfast Eaters

Women who self-report eating breakfast regularly.

No interventions assigned to this group

Non-Breakfast Eaters

Women who self-report skipping breakfast regularly.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role collaborator

USDA, Western Human Nutrition Research Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nancy Keim, PhD

Role: PRINCIPAL_INVESTIGATOR

WHNRC, ARS, University of California Davis

Locations

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Western Human Nutrition Center, University of California Davis

Davis, California, United States

Site Status

Countries

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United States

References

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Forester SM, Widaman AM, Krishnan S, Witbracht MG, Horn WF, Laugero KD, Keim NL. A Clear Difference Emerges in Hormone Patterns Following a Standard Midday Meal in Young Women Who Regularly Eat or Skip Breakfast. J Nutr. 2018 May 1;148(5):685-692. doi: 10.1093/jn/nxy020.

Reference Type DERIVED
PMID: 29897486 (View on PubMed)

Other Identifiers

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WHNRC 213098-1

Identifier Type: -

Identifier Source: org_study_id

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