Egg Diet to Improve Metabolic Health and Function

August 16, 2017 updated by: Kevin Fontaine, University of Alabama at Birmingham

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35223
        • University of Alabama at Birmingham

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

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Egg-based diet (EBD)
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.
Other: Egg-based diet (EBD)
Participants will be asked to consume a carbohydrate-restricted diet including whole eggs for 8 weeks. Eggs will be provided.
Placebo Comparator: Carbohydrate-based diet (CBD)
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.
Other: Carbohydrate-based diet (CBD)
Participants will be asked to consume a low fat, carbohydrate-based diet for 8 weeks. Breakfast food items will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA)
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in visceral adipose tissue as measured by magnetic resonance imaging (MRI)
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in total lean mass as measured by DXA
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in subcutaneous abdominal adipose tissue as measured by MRI
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in thigh intermuscular adipose tissue as measured by MRI
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in thigh skeletal muscle volume as measured by MRI
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in thigh subcutaneous adipose tissue as measured by MRI
Time Frame: 8 weeks after baseline
8 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in pro-inflammatory markers, Interleukin (IL)-6
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in pro-inflammatory marker, hsCRP
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in pro-inflammatory marker, Tumor Necrosis Factor (TNF)-α
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in metabolic hormone adiponectin
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in metabolic hormone leptin
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in metabolic hormone insulin
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in markers of oxidative stress : isoprostanes
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in markers of oxidative stress : protein carbonyls
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in markers of oxidative stress : total anti-oxidants
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in the lipid profile: triglycerides
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in the lipid profile: total cholesterol
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in the lipid profile: HDL-C
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in the lipid profile: LDL
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in physical function: Short Physical Performance Battery
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in physical function : muscle strength
Time Frame: 8 weeks after baseline
8 weeks after baseline
Changes in quality of life (SF-36 Health Survey).
Time Frame: 8 weeks after baseline
8 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

American Egg Board

Investigators

  • Principal Investigator: Kevin M Fontaine, 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.

General Publications

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

January 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

April 28, 2016

First Submitted That Met QC Criteria

May 2, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Actual)

August 21, 2017

Last Update Submitted That Met QC Criteria

August 16, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F141016101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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