The Hormonal and Behavioral Impact of Eating Breakfast | NCT01427556

Studies
The Hormonal and Behavioral Impact of Eating Breakfast

NCT01427556

Sponsor

USDA, Western Human Nutrition Research Center

Status

Completed

Last Update Posted

Aug 18, 2014Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Eating Behavior

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Mar 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Aug 30, 2011

First Submission Date that Met QC Criteria

Aug 30, 2011

First Posted Date

Sep 1, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2014

Last Update Posted Date

Aug 18, 2014Estimated

Name	Class
USDA Beltsville Human Nutrition Research Center	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Breakfast Eaters		Women who self-report eating breakfast regularly.
Non-Breakfast Eaters		Women who self-report skipping breakfast regularly.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nancy Keim, PhD	WHNRC, ARS, University of California Davis	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Western Human Nutrition Center, University of California Davis		Davis	California	95616	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29897486	Derived	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.

ID	Term
D001522	Behavior, Animal
D001519	Behavior