Balanced (Egg) Protein During Obesity Reduction: Differential Responses of Insulin Resistance by Race
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Change from Baseline Insulin Resistance at 4 months
研究概览
简要总结
The purpose of the trial is to assess the effects of combining regular, generous intakes of high quality protein (with substantial amounts provided from whole eggs and egg whites) with calorie restriction on insulin resistance and weight loss (along with function, body composition, racial disparities, and a number of secondary outcomes) in black and white older adults with prediabetes who are participating in a 4-month intervention. The investigators will compare these effects to the same outcomes with a control group consuming a traditional control regimen of calorie restriction over the same duration.
详细描述
Older (>60 yrs) men and women (50% African American, 50% white) who are obese (BMI >30 kg/m2) and have pre-diabetes will be randomly assigned (1:1 ratio; couples randomized together) to one to two treatment groups: 1) Weight loss intervention (WL-Control; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, protein~0.8g/g/d; and 2) High protein weight loss intervention (WL-Protein; n = 20): subjects follow a calorie-reduction diet for a weight loss of ≥10%, with a high proportion of high quality protein (> 30g protein, 3/day, 60-70% egg protein). Primary (insulin resistance/sensitivity, weight loss) and secondary outcomes (physical function, body composition, diet adherence, cognitive function, readiness to change) will be measured at 0 and 4 months.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60 years
- •Identifies as Caucasian/white or African-American/black
- •Obese body weight (>30 kg/m2)
- •Able to speak and understand spoken and written English
- •Elevated fasting plasma glucose (≥95 and <126 mg/dL)
- •Age-normal Kidney function (≥ 45 mL/min/1.73 m2)
排除标准
- •Body weight > 224 kg (limit of the BodPod)
- •Treated or untreated diabetes (prior diagnosis, treatment, or fasting blood glucose ≥126 mg/dL)
- •Presence of unstable, acutely symptomatic, or life-limiting illness
- •Positive screen for dementia using Mini-Cog evaluation tool
- •Neurological conditions causing functional or cognitive impairments
- •History of significant weight instability (defined as > 10 pounds weight gain or loss over 6 months prior to study participation)
- •Allergy or intolerance to egg products
- •Unwillingness or inability to be randomized to any one of two intervention groups, submit to all study testing, or continuously participate in a randomly assigned lifestyle intervention program for four months
- •Inability to walk independently
- •Unable to give consent
- •Unable to complete written recording forms including journals of eating and exercise behaviors.
- •Current use of the following medications: monoamine oxidase inhibitors, prescription weight loss medications, insulin, metformin or any other hypoglycemic agent
- •Primary Care Physician advises against participation
- •Unusually or unstable renal function
结局指标
主要结局
Change from Baseline Insulin Resistance at 4 months
时间窗: 0 to 4 months
Blood glucose and insulin levels in whole blood will be used to compute HOMA-IR (= glucose mg/dL x insulin mg/dL/405)
Change from Baseline Body weight at 4 months
时间窗: 0 to 4 months
Weight loss as measured in light clothing on a dedicated scale.
次要结局
- Change from baseline Symbol digit modalities test at 4 months(0 to 4 months)
- Change from baseline Short Physical Performance Battery at 4 months(0 to 4 months)
- Change from baseline fat mass (%) at 4 months(0 to 4 months)
- Change from baseline fat mass (kgs) at 4 months(0 to 4 months)
- Change from baseline 8-foot up and Go time at 4 months(0 to 4 months)
- Change from baseline 6-minute walk (meters) at 4 months(0 to 4 months)
- Change from baseline 30-second chair stands (number of stands) at 4 months(0 to 4 months)
- Change from baseline total calories at 4 months(0 to 4 months)
- Change from baseline micronutrient intake at 4 months(0 to 4 months)
- Change from baseline handgrip strength at 4 months(0 to 4 months)
- Change from baseline grooved pegboard time at 4 months(0 to 4 months)
- Change from baseline hip circumference at 4 months(0 to 4 months)
- Change from baseline lean mass (kgs) at 4 months(0 to 4 months)
- Change from baseline minimal waist circumference at 4 months(0 to 4 months)
- Change from baseline lean mass (%) at 4 months(0 to 4 months)
- Change from baseline macronutrient intake at 4 months(0 to 4 months)
- Change from baseline Profile of Mood States at 4 months(0 to 4 months)
- Change from baseline Perceived Stress Scale at 4 months(0 to 4 months)
- Change from Baseline Insulin Sensitivity at 4 months(0 to 4 months)
- Change from baseline umbilical waist circumference at 4 months(0 to 4 months)
- Change from baseline Hopkins Verbal Learning Test at 4 months(0 to 4 months)
- Change from baseline Trail Making Test at 4 months(0 to 4 months)