An Egg Based Breakfast Maintains Flexibility in Older Adults

NCT ID: NCT03164200

Last Updated: 2017-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-14

Study Completion Date

2013-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Heart Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Patients were randomized to either a egg breakfast or a carbohydrate breakfast

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High fat breakfast

45% fat 35% Carbohydrate 20% protein

Group Type EXPERIMENTAL

High fat breakfast

Intervention Type OTHER

High fat breakfast

Higher carbohydrate breakfast

60% carbohydrate 20% fat 20% protein

Group Type EXPERIMENTAL

Higher carbohydrate breakfast

Intervention Type OTHER

Higher carbohydrate breakfast

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High fat breakfast

High fat breakfast

Intervention Type OTHER

Higher carbohydrate breakfast

Higher carbohydrate breakfast

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Barbara Gower

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Barbara Gower, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29490097 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2148

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of Meal Macronutrients on Postprandial Lipids
NCT07313787 NOT_YET_RECRUITING PHASE2
Diet and Health in Adults With Metabolic Syndrome
NCT03935048 ACTIVE_NOT_RECRUITING NA