- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03164200
An Egg Based Breakfast Maintains Flexibility in Older Adults
May 22, 2017 updated by: Barbara Gower, University of Alabama at Birmingham
Aging is associated with an increased risk for metabolic diseases, such as type 2 diabetes and cardiovascular disease.
There is reason to believe that the time of day when specific food groups are eaten affects this risk.
The investigators propose that eating foods made up of fat and protein (such as eggs) in the morning for breakfast, rather than foods made up of carbohydrates (such as white-bread toast or sugary cereal) may promote a healthier metabolism.
This is because the body is designed to burn fat during times of fasting, such as overnight, during sleep.
Thus, the body is not prepared to burn sugar early in the morning, when most people eat breakfast.
Studies with mice have shown that a sugary breakfast meal inhibits the ability of the body to burn fat for the entire day.
In contrast, a breakfast meal with more fat enabled the animals to burn fat as well as other fuels throughout the day.
The ability to burn fat is thought to minimize risk for obesity, as well as related diseases such as type 2 diabetes and heart disease.
The purpose of this study is to determine if, in older adult humans, consumption of a lower-carbohydrate breakfast meal (relative to a higher-carbohydrate meal) is associated with a healthier metabolism.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Not Applicable
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
55 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
• Age 55-75
- Body mass index 24-29 kg/m2
Exclusion Criteria:
• Current practice of greater than 2h/wk of moderate intentional exercise
- Uncontrolled diabetes
- Unwillingness to eat study diets
- Use of any medication known to affect metabolism
- History of eating disorder
- Difficulty chewing and swallowing solid food
- Digestive diseases
- Cognitive impairment
- Depression
- Recent weight change (+/- 10 lbs. in the last 12 mo.)
- Poorly controlled blood pressure (SBP > 159 or DBP >95 mm Hg)
- History of non-skin cancer in the last 5 y
- Cardiovascular disease event in the past 6 mo.
- Severe pulmonary disease
- Renal failure
- Major liver dysfunction (elevation of liver transaminases >3x normal in past 2 y; current/recent smoker (within 6 mo.)
- Use of estrogen or testosterone replacement therapy
- Current use of oral corticosteroids >5 days/month on average
- Current use of medications for treatment of psychosis or manic-depressive illness
- Use of weight loss medications in the previous 3 months
- Unable to adhere to diet recommendations
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
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: High fat breakfast
45% fat 35% Carbohydrate 20% protein
|
High fat breakfast
|
|
Experimental: Higher carbohydrate breakfast
60% carbohydrate 20% fat 20% protein
|
Higher carbohydrate breakfast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Respiratory quotient (RQ, a measure of substrate oxidation)
Time Frame: 4 weeks
|
24 hour respiratory quotient will be measured using whole-room indirect calorimetry
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Barbara Gower, PhD, University of Alabama at Birmingham
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.
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 (Actual)
December 14, 2011
Primary Completion (Actual)
October 30, 2013
Study Completion (Actual)
October 30, 2013
Study Registration Dates
First Submitted
May 15, 2017
First Submitted That Met QC Criteria
May 22, 2017
First Posted (Actual)
May 23, 2017
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 22, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2148 (Inselspital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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