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临床试验/NCT01915030
NCT01915030已完成不适用

Protect The Impact of a High Protein Diet on the Preservation of Muscle Mass During Caloric Restriction in Middle Age and Elderly People

Wageningen University2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2012年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
2
主要终点
Change in Body composition

研究概览

简要总结

The present study is designed to investigate whether a high protein diet will preserve muscle mass during caloric restriction in older adults.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Overweight and obese subjects (BMI 27-40 kg/m2)
  • Waist circumference male:≥ 102 cm, female: ≥ 88 cm
  • Willingness and ability to comply with the protocol

排除标准

  • Renal insufficiency
  • Co-morbidities
  • Type 1 & 2 diabetics (Fasting glucose level ≥ 7 mmol/L)
  • Participation in weight loss program 3 months before the intervention
  • Participation of any heavy resistance-type exercise training (>1 wk) the last 2 y.
  • Intentional or unintentional weight loss (> 3 kg in the last 3 months)
  • Severe loss appetite
  • Diagnosed allergy to milk products
  • Gastric bypass
  • Supplements or medication use for weight loss
  • Participation in any other intervention trial
  • Women can only participate if they are postmenopausal (last period ≥ a year ago)

结局指标

主要结局

Change in Body composition

时间窗: baseline and 12 weeks

DEXA scan

次要结局

  • Physical performance(baseline and 12 weeks)
  • Blood related parameters(baseline and 12 weeks)
  • Muscle related parameters(baseline and 12 weeks)
  • Physical activity(baseline and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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