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

August 15, 2014 updated by: USDA, Western Human Nutrition Research Center

CCRC: 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Western Human Nutrition Center, University of California Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

One hundred and twenty pre-menopausal women, aged 20 to 45y, who report eating breakfast regularly or skipping breakfast regularly.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breakfast Eaters
Women who self-report eating breakfast regularly.
Non-Breakfast Eaters
Women who self-report skipping breakfast regularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
week 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Markers of nutrient metabolism
Time Frame: week 6
Blood glucose, insulin, lipids, and metabolic hormones will be measured.
week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA, Western Human Nutrition Research Center

Collaborators

USDA Beltsville Human Nutrition Research Center

Investigators

  • Principal Investigator: Nancy Keim, PhD, WHNRC, ARS, University of California Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 30, 2011

First Submitted That Met QC Criteria

August 30, 2011

First Posted (Estimate)

September 1, 2011

Study Record Updates

Last Update Posted (Estimate)

August 18, 2014

Last Update Submitted That Met QC Criteria

August 15, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • WHNRC 213098-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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