DiabetesNCT03164200
An Egg Based Breakfast Maintains Flexibility in Older Adults
A study testing High fat breakfast and Higher carbohydrate breakfast in people with Diabetes and Heart Diseases, run by University of Alabama at Birmingham.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Heart Diseases
- What is being tested?
- High fat breakfast and Higher carbohydrate breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2011to 30 Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Age 55-75
- Body mass index 24-29 kg/m2
Who cannot join
- • 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
Show all 21Show fewer
- 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
About this study
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.
- Conditions
- Diabetes, Heart Diseases
- Being tested
- High fat breakfast, Higher carbohydrate breakfast
- Medical subject headings
- Diabetes Mellitus, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat breakfastOther
High fat breakfast
Higher carbohydrate breakfastOther
Higher carbohydrate breakfast
| Study group | Role | What they receive |
|---|---|---|
| High fat breakfast | Experimental | 45% fat 35% Carbohydrate 20% protein Receives: Other: High fat breakfast |
| Higher carbohydrate breakfast | Experimental | 60% carbohydrate 20% fat 20% protein Receives: Other: Higher carbohydrate breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory quotient (RQ, a measure of substrate oxidation)
24 hour respiratory quotient will be measured using whole-room indirect calorimetry
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start14 Dec 2011
- Primary completion30 Oct 2013
- Study completion30 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Gower, University of Alabama at Birmingham
- Investigators
- Barbara Gower, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164200
- Sponsor's protocol ID
- 2148
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bush NC, Resuehr HES, Goree LL, Locher JL, Bray MS, Soleymani T, Gower BA. A High-Fat Compared with a High-Carbohydrate Breakfast Enhances 24-Hour Fat Oxidation in Older Adults. J Nutr. 2018 Feb 1;148(2):220-226. doi: 10.1093/jn/nxx040.
PubMed 29490097
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Egg Based Breakfast Maintains Flexibility in Older Adults
- ClinicalTrials.gov ID
- NCT03164200
- Acronym / sponsor ID
- 2148
- Conditions
- Diabetes, Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 14 Dec 2011 (actual)
- Primary completion
- 30 Oct 2013 (actual)
- Study completion
- 30 Oct 2013 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat breakfast | Experimental | Other: High fat breakfast45% fat 35% Carbohydrate 20% protein |
| Higher carbohydrate breakfast | Experimental | Other: Higher carbohydrate breakfast60% carbohydrate 20% fat 20% protein |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Age 55-75
Key exclusion criteria (21 listed)
- • Current practice of greater than 2h/wk of moderate intentional exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High fat breakfastHigh fat breakfast | Other | High fat breakfast |
| Higher carbohydrate breakfastHigher carbohydrate breakfast | Other | Higher carbohydrate breakfast |
Primary outcome
Respiratory quotient (RQ, a measure of substrate oxidation)
Time frame: 4 weeks
24 hour respiratory quotient will be measured using whole-room indirect calorimetry
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Derived from this study: PubMed 29490097Bush NC, Resuehr HES, Goree LL, Locher JL, Bray MS, Soleymani T, Gower BA. A High-Fat Compared with a High-Carbohydrate Breakfast Enhances 24-Hour Fat Oxidation in Older Adults. J Nutr. 2018 Feb 1;148(2):220-226. doi: 10.1093/jn/nxx040.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Gower, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing High fat breakfast and Higher carbohydrate breakfast in people with Diabetes and Heart Diseases, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory quotient (RQ, a measure of substrate oxidation) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03164200, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.