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| Name | Class |
|---|---|
| American Egg Board | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin M Fontaine, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35223 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34212125 | Derived | 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. | |
| 32817749 | Derived |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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. |
|
| 8 weeks after baseline |
| Changes in metabolic hormone adiponectin | 8 weeks after baseline |
| Changes in metabolic hormone leptin | 8 weeks after baseline |
| Changes in metabolic hormone insulin | 8 weeks after baseline |
| Changes in markers of oxidative stress : isoprostanes | 8 weeks after baseline |
| Changes in markers of oxidative stress : protein carbonyls | 8 weeks after baseline |
| Changes in markers of oxidative stress : total anti-oxidants | 8 weeks after baseline |
| Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp | 8 weeks after baseline |
| Changes in the lipid profile: triglycerides | 8 weeks after baseline |
| Changes in the lipid profile: total cholesterol | 8 weeks after baseline |
| Changes in the lipid profile: HDL-C | 8 weeks after baseline |
| Changes in the lipid profile: LDL | 8 weeks after baseline |
| Changes in physical function: Short Physical Performance Battery | 8 weeks after baseline |
| Changes in physical function : muscle strength | 8 weeks after baseline |
| Changes in quality of life (SF-36 Health Survey). | 8 weeks after baseline |
| 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |