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临床试验/NCT02760641
NCT02760641已完成不适用

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

University of Alabama at Birmingham2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Changes in total fat mass as measured by dual-energy X-ray absorptiometry (DXA)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

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.

干预措施: Egg-based diet (EBD) (Other)

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.

干预措施: Carbohydrate-based diet (CBD) (Other)

结局指标

主要结局

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

时间窗: 8 weeks after baseline

Changes in total lean mass as measured by DXA

时间窗: 8 weeks after baseline

Changes in subcutaneous abdominal adipose tissue as measured by MRI

时间窗: 8 weeks after baseline

Changes in thigh intermuscular adipose tissue as measured by MRI

时间窗: 8 weeks after baseline

Changes in thigh subcutaneous adipose tissue as measured by MRI

时间窗: 8 weeks after baseline

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

时间窗: 8 weeks after baseline

Changes in thigh skeletal muscle volume as measured by MRI

时间窗: 8 weeks after baseline

次要结局

  • Changes in metabolic hormone insulin(8 weeks after baseline)
  • Changes in metabolic hormone adiponectin(8 weeks after baseline)
  • Changes in physical function : muscle strength(8 weeks after baseline)
  • Changes in the lipid profile: LDL(8 weeks after baseline)
  • Changes in metabolic hormone leptin(8 weeks after baseline)
  • Changes in markers of oxidative stress : isoprostanes(8 weeks after baseline)
  • Changes in markers of oxidative stress : total anti-oxidants(8 weeks after baseline)
  • Changes in the lipid profile: HDL-C(8 weeks after baseline)
  • Changes in pro-inflammatory markers, Interleukin (IL)-6(8 weeks after baseline)
  • Changes in pro-inflammatory marker, Tumor Necrosis Factor (TNF)-α(8 weeks after baseline)
  • Changes in the lipid profile: triglycerides(8 weeks after baseline)
  • Changes in pro-inflammatory marker, hsCRP(8 weeks after baseline)
  • Changes in markers of oxidative stress : protein carbonyls(8 weeks after baseline)
  • Changes in insulin sensitivity with euglycemic-hyperinsulinemic clamp(8 weeks after baseline)
  • Changes in the lipid profile: total cholesterol(8 weeks after baseline)
  • Changes in physical function: Short Physical Performance Battery(8 weeks after baseline)
  • Changes in quality of life (SF-36 Health Survey).(8 weeks after baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kevin Fontaine

Principal Investigators

University of Alabama at Birmingham

研究点 (2)

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