Egg Diet to Improve Metabolic Health and Function

NCT02760641 | Completed

• 1 other identifier: F141016101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

obesity; low carbohydrate diet; metabolism; body composition; visceral fat; older adults; insulin sensitivity

Outcome Measures

Primary Outcomes (7)

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

  8 weeks after baseline

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

  8 weeks after baseline

• Changes in total lean mass as measured by DXA

  8 weeks after baseline

• Changes in subcutaneous abdominal adipose tissue as measured by MRI

  8 weeks after baseline

• Changes in thigh intermuscular adipose tissue as measured by MRI

  8 weeks after baseline

• Changes in thigh skeletal muscle volume as measured by MRI

  8 weeks after baseline

• Changes in thigh subcutaneous adipose tissue as measured by MRI

  8 weeks after baseline

Secondary Outcomes (17)

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

  8 weeks after baseline

• Changes in pro-inflammatory marker, hsCRP

  8 weeks after baseline

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

  8 weeks after baseline

• Changes in metabolic hormone adiponectin

  8 weeks after baseline

• Changes in metabolic hormone leptin

  8 weeks after baseline

Study Arms (2)

Egg-based diet (EBD)

EXPERIMENTAL

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.

Other: Egg-based diet (EBD)

Carbohydrate-based diet (CBD)

PLACEBO COMPARATOR

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.

Other: Carbohydrate-based diet (CBD)

Interventions

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.

Egg-based diet (EBD)

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.

Carbohydrate-based diet (CBD)

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• American Egg Board: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

Related Publications (2)

• 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.

  PMID: 34212125 DERIVED

• 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.

  PMID: 32817749 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Kevin M Fontaine, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigators

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: May 3, 2016
• Study Start: January 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 21, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)