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Egg Diet to Improve Metabolic Health and Function

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Kevin Fontaine, University of Alabama at Birmingham
Sponsor:
Collaborator:
American Egg Board
Information provided by (Responsible Party):
Kevin Fontaine, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT02760641
First received: April 28, 2016
Last updated: March 30, 2017
Last verified: October 2016
  Purpose
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 Intervention
Obesity Other: Egg-based diet (EBD) Other: Carbohydrate-based diet (CBD)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Investigator
Primary Purpose: Treatment
Official Title: Does an Egg-Rich Diet Improve Metabolic Health and Function in Obese Older Adults

Further study details as provided by Kevin Fontaine, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 44
Study Start Date: January 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02760641

Contacts
Contact: Kevin M Fontaine, PhD 205-934-7050 kfontai1@uab.edu
Contact: Amy M Goss, PhD RD 205 -934-7050 amymiski@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35223
Contact: Kevin R Fontaine, PhD    205-934-7050    kfontai1@uab.edu   
Contact: Amy M Goss, PhD. RD.    205-934-7050    amymiski@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
American Egg Board
Investigators
Principal Investigator: Kevin M Fontaine, PhD University of Alabama at Birmingham
  More Information

Responsible Party: Kevin Fontaine, Principal Investigators, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02760641     History of Changes
Other Study ID Numbers: F141016101
Study First Received: April 28, 2016
Last Updated: March 30, 2017
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

ClinicalTrials.gov processed this record on July 24, 2017