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Egg Diet to Improve Metabolic Health and Function

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ClinicalTrials.gov Identifier: NCT02760641
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Kevin Fontaine, University of Alabama at Birmingham

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Other: Egg-based diet (EBD) Other: Carbohydrate-based diet (CBD) Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Does an Egg-Rich Diet Improve Metabolic Health and Function in Obese Older Adults
Study Start Date : January 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA) [ Time Frame: 8 weeks after baseline ]
  2. Changes in visceral adipose tissue as measured by magnetic resonance imaging (MRI) [ Time Frame: 8 weeks after baseline ]
  3. Changes in total lean mass as measured by DXA [ Time Frame: 8 weeks after baseline ]
  4. Changes in subcutaneous abdominal adipose tissue as measured by MRI [ Time Frame: 8 weeks after baseline ]
  5. Changes in thigh intermuscular adipose tissue as measured by MRI [ Time Frame: 8 weeks after baseline ]
  6. Changes in thigh skeletal muscle volume as measured by MRI [ Time Frame: 8 weeks after baseline ]
  7. Changes in thigh subcutaneous adipose tissue as measured by MRI [ Time Frame: 8 weeks after baseline ]

Secondary Outcome Measures :
  1. Changes in pro-inflammatory markers, Interleukin (IL)-6 [ Time Frame: 8 weeks after baseline ]
  2. Changes in pro-inflammatory marker, hsCRP [ Time Frame: 8 weeks after baseline ]
  3. Changes in pro-inflammatory marker, Tumor Necrosis Factor (TNF)-α [ Time Frame: 8 weeks after baseline ]
  4. Changes in metabolic hormone adiponectin [ Time Frame: 8 weeks after baseline ]
  5. Changes in metabolic hormone leptin [ Time Frame: 8 weeks after baseline ]
  6. Changes in metabolic hormone insulin [ Time Frame: 8 weeks after baseline ]
  7. Changes in markers of oxidative stress : isoprostanes [ Time Frame: 8 weeks after baseline ]
  8. Changes in markers of oxidative stress : protein carbonyls [ Time Frame: 8 weeks after baseline ]
  9. Changes in markers of oxidative stress : total anti-oxidants [ Time Frame: 8 weeks after baseline ]
  10. Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp [ Time Frame: 8 weeks after baseline ]
  11. Changes in the lipid profile: triglycerides [ Time Frame: 8 weeks after baseline ]
  12. Changes in the lipid profile: total cholesterol [ Time Frame: 8 weeks after baseline ]
  13. Changes in the lipid profile: HDL-C [ Time Frame: 8 weeks after baseline ]
  14. Changes in the lipid profile: LDL [ Time Frame: 8 weeks after baseline ]
  15. Changes in physical function: Short Physical Performance Battery [ Time Frame: 8 weeks after baseline ]
  16. Changes in physical function : muscle strength [ Time Frame: 8 weeks after baseline ]
  17. Changes in quality of life (SF-36 Health Survey). [ Time Frame: 8 weeks after baseline ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760641


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35223
Sponsors and Collaborators
University of Alabama at Birmingham
American Egg Board
Investigators
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Principal Investigator: Kevin M Fontaine, PhD University of Alabama at Birmingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kevin Fontaine, Principal Investigators, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02760641    
Other Study ID Numbers: F141016101
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kevin Fontaine, University of Alabama at Birmingham:
obesity
low carbohydrate diet
metabolism
body composition
 visceral fat
older adults
insulin sensitivity
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight