NCT02760641CompletedNot Applicable

Does an Egg-Rich Diet Improve Metabolic Health and Function in Obese Older Adults

University of Alabama at Birmingham2 sites in 1 country34 target enrollmentStarted: January 2015Last updated: August 21, 2017

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: University of Alabama at Birmingham
Enrollment: 34
Locations: 2
Primary Endpoint: Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

Detailed Description

The purpose of this study is to determine the effects of change in diet quality (carbohydrate restriction versus fat restriction) on body composition, fat distribution, cardiometabolic risk factors, physical function, and quality of life in aging adults with obesity. Data from previous studies support the hypothesis that consumption of lower-CHO, higher-fat food sources rich in high-quality proteins and essential fatty acids, such as whole eggs, has beneficial effects on metabolic health. The study will test the hypothesis that a reduced CHO higher- fat, egg-rich diet induces selective depletion of total and abdominal adiposity, preserves lean mass, and reduces inflammation and oxidative stress. In turn, these favorable changes in body composition, fat distribution, and metabolic health will confer improvements in physical function in obese, aging adults.

Results from this study will form an empirical basis for developing an easily implemented, non-pharmacologic treatment (i.e. change diet quality by incorporating more low carbohydrate, whole foods such as eggs) to prevent or reverse sarcopenia and other age-related diseases of metabolic origins.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Single (Investigator)

Eligibility Criteria

Ages: 60 Years to 75 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•between 60-75 years of age,
•have a BMI ranging from 30-40 kg/m2,
•sedentary (<2h/wk of intentional exercise, and agree to maintain their level of activity throughout the study).

Exclusion Criteria

•those with uncontrolled diabetes,
•unwilling to eat the prescribed diets,
•recent weight change (+/- 10 lbs. in previous year),
•history of eating disorder,
•difficulty chewing and swallowing solid food,
•digestive diseases,
•cognitive impairment,
•uncontrolled blood pressure (systolic blood pressure > 159 or diastolic blood pressure >95 mm Hg),
•history of non-skin cancer in the last 5 years,
•cardiovascular disease event; severe pulmonary disease; renal failure; major liver dysfunction,
•current/recent smoker,
•use of estrogen or testosterone replacement therapy,
•current use of oral corticosteroids (>5 d/mth),
•using medications for treatment of psychosis or manic-depressive illness, and
•dependence on others for food procurement or preparation.

Arms & Interventions

Egg-based diet (EBD)

Experimental

This arm will provide ≤25% energy from CHO, 25% energy from protein, and ≥50% energy from fat. EBD participants will be asked to consume ≥2 eggs per day along with other protein sources including meat, fish, pork, and poultry. Carbohydrate (CHO) sources will be primarily derived from leafy greens and non-starchy vegetables and CHO intake will be equally distributed across meals throughout the day.

Intervention: Egg-based diet (EBD) (Other)

Carbohydrate-based diet (CBD)

Placebo Comparator

The CBD group will be asked to avoid whole egg consumption when possible during the 8 week intervention period. They will be counseled to consume a low fat diet with 55:25:20 %energy from CHO:protein:fat. This diet will place an emphasis on consuming lean meats, low fat dairy, whole grains, legumes, fruits and vegetables.

Intervention: Carbohydrate-based diet (CBD) (Other)