Skip to main content
OpenTrials
Completed

NCT Number: NCT02760641

Egg Diet to Improve Metabolic Health and Function

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Egg-based diet (EBD)

Other

Participants will be asked to consume a carbohydrate-restricted diet including whole eggs for 8 weeks. Eggs will be provided.

Carbohydrate-based diet (CBD)

Other

Participants will be asked to consume a low fat, carbohydrate-based diet for 8 weeks. Breakfast food items will be provided.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • American Egg Board

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 3, 2016
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.