The Hormonal and Behavioral Impact of Eating Breakfast

NCT01427556 | Completed

• 1 other identifier: WHNRC 213098-1
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Behavior

Keywords

Food intake; Breakfast eating

Outcome Measures

Primary Outcomes (1)

• Food Intake Behavior

  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 Outcomes (1)

• Markers of nutrient metabolism

  week 6

Study Arms (2)

Breakfast Eaters

Women who self-report eating breakfast regularly.

Non-Breakfast Eaters

Women who self-report skipping breakfast regularly.

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Pre-menopausal women (as determined by self-report of menstrual history and confirmation with plasma FSH)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• USDA Beltsville Human Nutrition Research Center: collaborator

Study Sites (1)

Western Human Nutrition Center, University of California Davis

Davis, California, 95616, United States

Location

Related Publications (1)

• 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.

  PMID: 29897486 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and saliva samples will be retained.

MeSH Terms

Conditions

Feeding Behavior

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Study Officials

• Nancy Keim, PhD

  WHNRC, ARS, University of California Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2011
• First Posted: September 1, 2011
• Study Start: August 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 18, 2014

Record last verified: 2014-08

Locations

US (1)