Egg Diet to Improve Metabolic Health and Function

NCT ID: NCT02760641

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-07-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Egg-based diet (EBD)

Intervention Type: 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)

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.

Group Type: PLACEBO_COMPARATOR

Carbohydrate-based diet (CBD)

Intervention Type: OTHER

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

Interventions

Egg-based diet (EBD)

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

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Egg Board

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Kevin Fontaine

Principal Investigators

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin M Fontaine, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34212125 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32817749 (View on PubMed)

Other Identifiers

F141016101

Identifier Type: -

Identifier Source: org_study_id