Clinical trial NCT02760641: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
low carbohydrate diet
metabolism
body composition
visceral fat
older adults
insulin sensitivity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Egg Board
First posted: 2016-05-03
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA)
timeFrame: 8 weeks after baseline
measure: Changes in visceral adipose tissue as measured by magnetic resonance imaging (MRI)
timeFrame: 8 weeks after baseline
measure: Changes in total lean mass as measured by DXA
timeFrame: 8 weeks after baseline
measure: Changes in subcutaneous abdominal adipose tissue as measured by MRI
timeFrame: 8 weeks after baseline
measure: Changes in thigh intermuscular adipose tissue as measured by MRI
timeFrame: 8 weeks after baseline
measure: Changes in thigh skeletal muscle volume as measured by MRI
timeFrame: 8 weeks after baseline
measure: Changes in thigh subcutaneous adipose tissue as measured by MRI
timeFrame: 8 weeks after baseline
Secondary outcomes:
measure: Changes in pro-inflammatory markers, Interleukin (IL)-6
timeFrame: 8 weeks after baseline
measure: Changes in pro-inflammatory marker, hsCRP
timeFrame: 8 weeks after baseline
measure: Changes in pro-inflammatory marker, Tumor Necrosis Factor (TNF)-α
timeFrame: 8 weeks after baseline
measure: Changes in metabolic hormone adiponectin
timeFrame: 8 weeks after baseline
measure: Changes in metabolic hormone leptin
timeFrame: 8 weeks after baseline
measure: Changes in metabolic hormone insulin
timeFrame: 8 weeks after baseline
measure: Changes in markers of oxidative stress : isoprostanes
timeFrame: 8 weeks after baseline
measure: Changes in markers of oxidative stress : protein carbonyls
timeFrame: 8 weeks after baseline
measure: Changes in markers of oxidative stress : total anti-oxidants
timeFrame: 8 weeks after baseline
measure: Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp
timeFrame: 8 weeks after baseline
measure: Changes in the lipid profile: triglycerides
timeFrame: 8 weeks after baseline
measure: Changes in the lipid profile: total cholesterol
timeFrame: 8 weeks after baseline
measure: Changes in the lipid profile: HDL-C
timeFrame: 8 weeks after baseline
measure: Changes in the lipid profile: LDL
timeFrame: 8 weeks after baseline
measure: Changes in physical function: Short Physical Performance Battery
timeFrame: 8 weeks after baseline
measure: Changes in physical function : muscle strength
timeFrame: 8 weeks after baseline
measure: Changes in quality of life (SF-36 Health Survey).
timeFrame: 8 weeks after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kevin M Fontaine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.