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ObesityNCT02760641

Egg Diet to Improve Metabolic Health and Function

A study testing Egg-based diet (EBD) and Carbohydrate-based diet (CBD) in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Egg-based diet (EBD) and Carbohydrate-based diet (CBD)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteUnited States
Study dates
Jan 2015to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35223

Other trials in United States

About this study

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

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.

Read the 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
Being tested
Egg-based diet (EBD), Carbohydrate-based diet (CBD)
Keywords
obesity, low carbohydrate diet, metabolism, body composition, visceral fat, older adults, insulin sensitivity
Medical subject headings
Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT02760641
Study groupRoleWhat they receive
Egg-based diet (EBD)ExperimentalThis 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.
Receives: Other: Egg-based diet (EBD)
Carbohydrate-based diet (CBD)Placebo comparatorThe 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.
Receives: Other: Carbohydrate-based diet (CBD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA)

    Measured: 8 weeks after baseline

  2. Changes in visceral adipose tissue as measured by magnetic resonance imaging (MRI)

    Measured: 8 weeks after baseline

  3. Changes in total lean mass as measured by DXA

    Measured: 8 weeks after baseline

  4. Changes in subcutaneous abdominal adipose tissue as measured by MRI

    Measured: 8 weeks after baseline

  5. Changes in thigh intermuscular adipose tissue as measured by MRI

    Measured: 8 weeks after baseline

  6. Changes in thigh skeletal muscle volume as measured by MRI

    Measured: 8 weeks after baseline

  7. Changes in thigh subcutaneous adipose tissue as measured by MRI

    Measured: 8 weeks after baseline

Secondary outcomes (17)

  1. Changes in pro-inflammatory markers, Interleukin (IL)-6

    Measured: 8 weeks after baseline

  2. Changes in pro-inflammatory marker, hsCRP

    Measured: 8 weeks after baseline

  3. Changes in pro-inflammatory marker, Tumor Necrosis Factor (TNF)-α

    Measured: 8 weeks after baseline

  4. Changes in metabolic hormone adiponectin

    Measured: 8 weeks after baseline

  5. Changes in metabolic hormone leptin

    Measured: 8 weeks after baseline

  6. Changes in metabolic hormone insulin

    Measured: 8 weeks after baseline

  7. Changes in markers of oxidative stress : isoprostanes

    Measured: 8 weeks after baseline

  8. Changes in markers of oxidative stress : protein carbonyls

    Measured: 8 weeks after baseline

  9. Changes in markers of oxidative stress : total anti-oxidants

    Measured: 8 weeks after baseline

  10. Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp

    Measured: 8 weeks after baseline

  11. Changes in the lipid profile: triglycerides

    Measured: 8 weeks after baseline

  12. Changes in the lipid profile: total cholesterol

    Measured: 8 weeks after baseline

  13. Changes in the lipid profile: HDL-C

    Measured: 8 weeks after baseline

  14. Changes in the lipid profile: LDL

    Measured: 8 weeks after baseline

  15. Changes in physical function: Short Physical Performance Battery

    Measured: 8 weeks after baseline

  16. Changes in physical function : muscle strength

    Measured: 8 weeks after baseline

  17. Changes in quality of life (SF-36 Health Survey).

    Measured: 8 weeks after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02760641
Sponsor's protocol ID
F141016101
Status last verified
Oct 2016
First submitted
28 Apr 2016
Last updated
21 Aug 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Drake CE, Gower BA, Fontaine KR, Bryan DR, Goss AM. The Effect of a Very Low-Carbohydrate Diet on Intermuscular Adipose Tissue and Muscle Function in Older Adults With Obesity. Obesity (Silver Spring). 2026 Oct 6. doi: 10.1002/oby.70316. Online ahead of print.

    PubMed 42838121

  • 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.

    PubMed 34212125

  • 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.

    PubMed 32817749

Questions about this trial

What is this clinical trial studying?

A study testing Egg-based diet (EBD) and Carbohydrate-based diet (CBD) in people with Obesity, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA) (time frame: 8 weeks after baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02760641, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.

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Egg Diet to Improve Metabolic Health and Function | AzTrials