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Egg Diet to Improve Metabolic Health and Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 28, 2016
First Posted Date  ICMJE May 3, 2016
Last Update Posted Date August 21, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA) [ Time Frame: 8 weeks after baseline ]
  • Changes in visceral adipose tissue as measured by magnetic resonance imaging (MRI) [ Time Frame: 8 weeks after baseline ]
  • Changes in total lean mass as measured by DXA [ Time Frame: 8 weeks after baseline ]
  • Changes in subcutaneous abdominal adipose tissue as measured by MRI [ Time Frame: 8 weeks after baseline ]
  • Changes in thigh intermuscular adipose tissue as measured by MRI [ Time Frame: 8 weeks after baseline ]
  • Changes in thigh skeletal muscle volume as measured by MRI [ Time Frame: 8 weeks after baseline ]
  • Changes in thigh subcutaneous adipose tissue as measured by MRI [ Time Frame: 8 weeks after baseline ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • Changes in pro-inflammatory markers, Interleukin (IL)-6 [ Time Frame: 8 weeks after baseline ]
  • Changes in pro-inflammatory marker, hsCRP [ Time Frame: 8 weeks after baseline ]
  • Changes in pro-inflammatory marker, Tumor Necrosis Factor (TNF)-α [ Time Frame: 8 weeks after baseline ]
  • Changes in metabolic hormone adiponectin [ Time Frame: 8 weeks after baseline ]
  • Changes in metabolic hormone leptin [ Time Frame: 8 weeks after baseline ]
  • Changes in metabolic hormone insulin [ Time Frame: 8 weeks after baseline ]
  • Changes in markers of oxidative stress : isoprostanes [ Time Frame: 8 weeks after baseline ]
  • Changes in markers of oxidative stress : protein carbonyls [ Time Frame: 8 weeks after baseline ]
  • Changes in markers of oxidative stress : total anti-oxidants [ Time Frame: 8 weeks after baseline ]
  • Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp [ Time Frame: 8 weeks after baseline ]
  • Changes in the lipid profile: triglycerides [ Time Frame: 8 weeks after baseline ]
  • Changes in the lipid profile: total cholesterol [ Time Frame: 8 weeks after baseline ]
  • Changes in the lipid profile: HDL-C [ Time Frame: 8 weeks after baseline ]
  • Changes in the lipid profile: LDL [ Time Frame: 8 weeks after baseline ]
  • Changes in physical function: Short Physical Performance Battery [ Time Frame: 8 weeks after baseline ]
  • Changes in physical function : muscle strength [ Time Frame: 8 weeks after baseline ]
  • Changes in quality of life (SF-36 Health Survey). [ Time Frame: 8 weeks after baseline ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Egg Diet to Improve Metabolic Health and Function
Official Title  ICMJE Does an Egg-Rich Diet Improve Metabolic Health and Function in Obese Older Adults
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Egg-based diet (EBD)
  • 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.
    Intervention: Other: Carbohydrate-based diet (CBD)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2017)
34
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2016)
44
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02760641
Other Study ID Numbers  ICMJE F141016101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Kevin Fontaine, University of Alabama at Birmingham
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Alabama at Birmingham
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE American Egg Board
Investigators  ICMJE
Principal Investigator: Kevin M Fontaine, PhD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP