The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Metabolic Syndrome Risk Factors
研究概览
简要总结
The objective of this study is to determine the combined effects of a high-protein diet and high-intensity training on metabolic syndrome risk factors in women aged 30-65.
详细描述
High-protein diet interventions have been shown to be effective in reducing triglycerides and increasing high-density lipoprotein cholesterol concentrations. Low-volume, high-intensity cycling exercise has shown to elicit positive effects on metabolic syndrome risk factors such as triglyceride concentrations. The objective of this study was to determine the combined effects of a high-protein, reduced carbohydrate diet and high-intensity interval training on metabolic syndrome risk factors in women. The second primary aim is to investigate the effect of the macronutrient content of the post-exercise meal consumed following an acute bout of interval training on postprandial metabolism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 30-65 yrs of age, inclusive
- •Waist circumference > 88 cm.
- •Weight stable (within 2 kg) for past 6 mo
- •Sedentary/Low-active (defined as <300minutes/wk light or moderate activity, with no vigorous activity in last 6 months)
- •At risk for MetS [defined as having 2 of the following 4 factors: 1) hypertriglyceridemia defined as > 150 mg/mL, 2) low HDL cholesterol defined < 50 or on medication, 3) elevated blood pressure defined as > 130/>85 Hg or taking medications or 4) hyperglycemia defined as fasting blood glucose > 100 or glycated hemoglobin > 6.5 or taking medications.
- •Willing to be randomized to the four treatment groups
排除标准
- •Any chronic disease/condition that would not permit exercise or dietary restriction (including egg allergy or refusal to incorporate eggs into the diet) or alter interpretation of data. Examples include, but are not limited to:
- •cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease; 2) severe orthopedic, musculoskeletal or neuromuscular impairments that would contradict exercise; 3) sensory impairments that interfere with following directions; 4) diagnosis of dementia; 5) history of malignancy during the past 5 yr; 6) medication use that impacts primary outcomes of interest (e.g. statins); 7) weight greater than 400 pounds due to DXA weight and size limitations; 8) Uncontrolled blood pressure defined as > 160/>100 Hg.
研究组 & 干预措施
Higher Protein Diet (PRO)
干预措施: Higher PRO Diet (Other)
Higher Carbohydrate Diet (CARB)
干预措施: Higher CARB Diet (Other)
PRO & Interval Exercise (PRO+EX)
干预措施: Sprint Interval Exercise (Behavioral)
PRO & Interval Exercise (PRO+EX)
干预措施: Higher PRO Diet (Other)
CARB & Interval Exercise (CARB+EX)
干预措施: Sprint Interval Exercise (Behavioral)
CARB & Interval Exercise (CARB+EX)
干预措施: Higher CARB Diet (Other)
结局指标
主要结局
Metabolic Syndrome Risk Factors
时间窗: Change [Baseline to 6 Weeks]
1. Post-Prandial Lipemia (and/or metabolic responses including insulin, glucose, triglycerides and free-fatty acids) to: a) a high fat meal challenge and b) a meal challenge similar to the higher protein or carbohydrate treatment arm. After an overnight fast and baseline blood draws, participants will consume a small meal and have their blood sampled every 30 minutes for 3 hours. 2. Biomarkers for Cardiovascular Disease and Diabetes Mellitus. Fasting blood samples for serum lipids, glucose, insulin and systemic inflammation (C-reactive protein) will be taken after an overnight fast.
次要结局
- Satiety(Change [Baseline to 6 weeks])
研究者
Ellen Evans
Associate Professor, Principal Investigator
University of Georgia