ClinicalTrials.gov

History of Changes for Study: NCT02760641
Egg Diet to Improve Metabolic Health and Function
Latest version (submitted August 16, 2017) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 May 2, 2016 None (earliest Version on record)
2 October 25, 2016 Study Status
3 March 30, 2017 Study Status
4 August 16, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

Scroll up to access the controls

Study NCT02760641
Submitted Date:  May 2, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: F141016101
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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2016
Overall Status: Recruiting
Study Start: January 2015
Primary Completion: September 2016 [Anticipated]
Study Completion: September 2016 [Anticipated]
First Submitted: April 28, 2016
First Submitted that
Met QC Criteria:
May 2, 2016
First Posted: May 3, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
May 2, 2016
Last Update Posted: May 3, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: University of Alabama at Birmingham
Responsible Party: Principal Investigator
Investigator: Kevin Fontaine
Official Title: Principal Investigators
Affiliation: University of Alabama at Birmingham
Collaborators: American Egg Board
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.

Open or close this module Conditions
Conditions: Obesity
Keywords: obesity
low carbohydrate diet
metabolism
body composition
visceral fat
older adults
insulin sensitivity
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Single (Investigator)
Allocation: Randomized
Enrollment: 44 [Anticipated]
Open or close this module Arms and Interventions
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.
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.
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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: Kevin M Fontaine, PhD
Telephone: 205-934-7050
Email: kfontai1@uab.edu
Central Contact Backup: Amy M Goss, PhD RD
Telephone: 205 -934-7050
Email: amymiski@uab.edu
Study Officials: Kevin M Fontaine, PhD
Principal Investigator
University of Alabama at Birmingham
Locations: United States, Alabama
University of Alabama at Birmingham
[Recruiting]
Birmingham, Alabama, United States, 35223
Contact:Contact: Kevin R Fontaine, PhD 205-934-7050 kfontai1@uab.edu
Contact:Contact: Amy M Goss, PhD. RD. 205-934-7050 amymiski@uab.edu
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services