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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03164200
Other study ID # 2148
Secondary ID
Status Completed
Phase N/A
First received May 15, 2017
Last updated May 22, 2017
Start date December 14, 2011
Est. completion date October 30, 2013

Study information

Verified date May 2017
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date October 30, 2013
Est. primary completion date October 30, 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
High fat breakfast
High fat breakfast
Higher carbohydrate breakfast
Higher carbohydrate breakfast

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Outcome

Type Measure Description Time frame Safety issue
Primary Respiratory quotient (RQ, a measure of substrate oxidation) 24 hour respiratory quotient will be measured using whole-room indirect calorimetry 4 weeks
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