Egg Diet to Improve Metabolic Health and Function

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

Tracking Information

• First Submitted Date: April 28, 2016
• First Posted Date: May 3, 2016
• Last Update Posted Date: August 21, 2017
• Study Start Date: January 2015
• Actual Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Egg Diet to Improve Metabolic Health and Function
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• 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

• 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 *

• Hoover SE, Il'yasova D, Fontaine KR, Spasojevic I, Gower BA, Goss AM. A Pilot Study of Associations Between Visceral Fat, IL-6, and Urinary F(2)-Isoprostanes in Older Adults Exposed to a Diet Intervention. Curr Dev Nutr. 2021 May 21;5(6):nzab082. doi: 10.1093/cdn/nzab082. eCollection 2021 Jun.
• Goss AM, Gower B, Soleymani T, Stewart M, Pendergrass M, Lockhart M, Krantz O, Dowla S, Bush N, Garr Barry V, Fontaine KR. Effects of weight loss during a very low carbohydrate diet on specific adipose tissue depots and insulin sensitivity in older adults with obesity: a randomized clinical trial. Nutr Metab (Lond). 2020 Aug 12;17:64. doi: 10.1186/s12986-020-00481-9. eCollection 2020.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 16, 2017): 34
• Original Estimated Enrollment (submitted: May 2, 2016): 44
• Actual Study Completion Date: July 2017
• Actual Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 60 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02760641
• Other Study ID Numbers: F141016101
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kevin Fontaine, University of Alabama at Birmingham
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Alabama at Birmingham
• Original Study Sponsor: Same as current
• Collaborators: American Egg Board

Investigators

• Principal Investigator: Kevin M Fontaine, PhD; University of Alabama at Birmingham

• PRS Account: University of Alabama at Birmingham
• Verification Date: October 2016