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Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome (EPHIT)

2015年9月24日 更新者:Ellen Evans、University of Georgia

The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

49

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Georgia
      • Athens、Georgia、美国、30602
        • Body Composition and Metabolism Lab, Ramsey Center, University of Georgia

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

30年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Higher Protein Diet (PRO)
Participants in the PRO and PRO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the high protein diet.
其他名称:
  • Higher Protein Reduced Carbohydrate Diet
有源比较器:Higher Carbohydrate Diet (CARB)
Participants in the CHO and CHO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the higher carbohydrate diet.
其他名称:
  • Conventional Higher Carbohydrate Diet
有源比较器:PRO & Interval Exercise (PRO+EX)
Participants in the PRO and PRO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the high protein diet.
其他名称:
  • Higher Protein Reduced Carbohydrate Diet
Participants will undergo sprint interval training on a cycle ergometer 3 times weekly for 6 weeks. Each training session begins with a 5-minute active warm-up. The warm-up is followed by 4-7 bouts of 30 seconds of all-out sprints and 4 minutes of active recovery.
其他名称:
  • 高强度训练
  • Sprint Interval Cycling
有源比较器:CARB & Interval Exercise (CARB+EX)
Participants in the CHO and CHO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the higher carbohydrate diet.
其他名称:
  • Conventional Higher Carbohydrate Diet
Participants will undergo sprint interval training on a cycle ergometer 3 times weekly for 6 weeks. Each training session begins with a 5-minute active warm-up. The warm-up is followed by 4-7 bouts of 30 seconds of all-out sprints and 4 minutes of active recovery.
其他名称:
  • 高强度训练
  • Sprint Interval Cycling

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Metabolic Syndrome Risk Factors
大体时间: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.
Change [Baseline to 6 Weeks]

次要结果测量

结果测量
措施说明
大体时间
Satiety
大体时间:Change [Baseline to 6 weeks]
Satiety will be assessed using questionnaires
Change [Baseline to 6 weeks]

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ellen M. Evans, PhD、University of Georgia
  • 首席研究员:Kirk J. Cureton, PhD、University of Georgia

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年2月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2012年6月15日

首先提交符合 QC 标准的

2012年6月15日

首次发布 (估计)

2012年6月19日

研究记录更新

最后更新发布 (估计)

2015年9月25日

上次提交的符合 QC 标准的更新

2015年9月24日

最后验证

2015年9月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

代谢综合征的临床试验

  • Sanford Health
    National Ataxia Foundation; Beyond Batten Disease Foundation; Pitt Hopkins Research Foundation; Cornelia... 和其他合作者
    招聘中
    线粒体疾病 | 色素性视网膜炎 | 重症肌无力 | 嗜酸性胃肠炎 | 多系统萎缩 | 平滑肌肉瘤 | 脑白质营养不良 | 肛瘘 | 脊髓小脑性共济失调3型 | 弗里德赖希共济失调 | 肯尼迪病 | 莱姆病 | 噬血细胞性淋巴组织细胞增生症 | 脊髓小脑性共济失调1型 | 脊髓小脑性共济失调2型 | 脊髓小脑共济失调6型 | 威廉姆斯综合症 | 先天性巨结肠症 | 糖原贮积病 | 川崎病 | 短肠综合症 | 低磷血症 | Leber先天性黑蒙 | 口臭 | 贲门失弛缓症 | 多发性内分泌肿瘤 | 利综合症 | 艾迪生病 | 多发性内分泌肿瘤 2 型 | 硬皮病 | 多发性内分泌肿瘤 1 型 | 多发性内分泌肿瘤 2A 型 | 多发性内分泌肿瘤 2B 型 | 非典型溶血性尿毒症综合征 | 胆道闭锁 | 痉挛性共济失调 | WAGR综合症 | 无虹膜 | 短暂性失忆症 | 马尾综合症 | Refsum 疾病 | 复发性呼吸... 及其他条件
    美国, 澳大利亚

Higher PRO Diet的临床试验

3
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