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Egg Diet to Improve Metabolic Health and Function

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Egg-based diet (EBD)
Carbohydrate-based diet (CBD)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, low carbohydrate diet, metabolism, body composition, visceral fat, older adults, insulin sensitivity

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Egg-based diet (EBD)

Carbohydrate-based diet (CBD)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA)
Changes in visceral adipose tissue as measured by magnetic resonance imaging (MRI)
Changes in total lean mass as measured by DXA
Changes in subcutaneous abdominal adipose tissue as measured by MRI
Changes in thigh intermuscular adipose tissue as measured by MRI
Changes in thigh skeletal muscle volume as measured by MRI
Changes in thigh subcutaneous adipose tissue as measured by MRI

Secondary Outcome Measures

Changes in pro-inflammatory markers, Interleukin (IL)-6
Changes in pro-inflammatory marker, hsCRP
Changes in pro-inflammatory marker, Tumor Necrosis Factor (TNF)-α
Changes in metabolic hormone adiponectin
Changes in metabolic hormone leptin
Changes in metabolic hormone insulin
Changes in markers of oxidative stress : isoprostanes
Changes in markers of oxidative stress : protein carbonyls
Changes in markers of oxidative stress : total anti-oxidants
Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp
Changes in the lipid profile: triglycerides
Changes in the lipid profile: total cholesterol
Changes in the lipid profile: HDL-C
Changes in the lipid profile: LDL
Changes in physical function: Short Physical Performance Battery
Changes in physical function : muscle strength
Changes in quality of life (SF-36 Health Survey).

Full Information

First Posted
April 28, 2016
Last Updated
August 16, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
American Egg Board
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1. Study Identification

Unique Protocol Identification Number
NCT02760641
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
American Egg Board

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, low carbohydrate diet, metabolism, body composition, visceral fat, older adults, insulin sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Egg-based diet (EBD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Carbohydrate-based diet (CBD)
Arm Type
Placebo Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Egg-based diet (EBD)
Intervention Description
Participants will be asked to consume a carbohydrate-restricted diet including whole eggs for 8 weeks. Eggs will be provided.
Intervention Type
Other
Intervention Name(s)
Carbohydrate-based diet (CBD)
Intervention Description
Participants will be asked to consume a low fat, carbohydrate-based diet for 8 weeks. Breakfast food items will be provided.
Primary Outcome Measure Information:
Title
Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA)
Time Frame
8 weeks after baseline
Title
Changes in visceral adipose tissue as measured by magnetic resonance imaging (MRI)
Time Frame
8 weeks after baseline
Title
Changes in total lean mass as measured by DXA
Time Frame
8 weeks after baseline
Title
Changes in subcutaneous abdominal adipose tissue as measured by MRI
Time Frame
8 weeks after baseline
Title
Changes in thigh intermuscular adipose tissue as measured by MRI
Time Frame
8 weeks after baseline
Title
Changes in thigh skeletal muscle volume as measured by MRI
Time Frame
8 weeks after baseline
Title
Changes in thigh subcutaneous adipose tissue as measured by MRI
Time Frame
8 weeks after baseline
Secondary Outcome Measure Information:
Title
Changes in pro-inflammatory markers, Interleukin (IL)-6
Time Frame
8 weeks after baseline
Title
Changes in pro-inflammatory marker, hsCRP
Time Frame
8 weeks after baseline
Title
Changes in pro-inflammatory marker, Tumor Necrosis Factor (TNF)-α
Time Frame
8 weeks after baseline
Title
Changes in metabolic hormone adiponectin
Time Frame
8 weeks after baseline
Title
Changes in metabolic hormone leptin
Time Frame
8 weeks after baseline
Title
Changes in metabolic hormone insulin
Time Frame
8 weeks after baseline
Title
Changes in markers of oxidative stress : isoprostanes
Time Frame
8 weeks after baseline
Title
Changes in markers of oxidative stress : protein carbonyls
Time Frame
8 weeks after baseline
Title
Changes in markers of oxidative stress : total anti-oxidants
Time Frame
8 weeks after baseline
Title
Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp
Time Frame
8 weeks after baseline
Title
Changes in the lipid profile: triglycerides
Time Frame
8 weeks after baseline
Title
Changes in the lipid profile: total cholesterol
Time Frame
8 weeks after baseline
Title
Changes in the lipid profile: HDL-C
Time Frame
8 weeks after baseline
Title
Changes in the lipid profile: LDL
Time Frame
8 weeks after baseline
Title
Changes in physical function: Short Physical Performance Battery
Time Frame
8 weeks after baseline
Title
Changes in physical function : muscle strength
Time Frame
8 weeks after baseline
Title
Changes in quality of life (SF-36 Health Survey).
Time Frame
8 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin M Fontaine, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35223
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34212125
Citation
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 F2-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.
Results Reference
derived
PubMed Identifier
32817749
Citation
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.
Results Reference
derived

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Egg Diet to Improve Metabolic Health and Function

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