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临床试验/NCT00700804
NCT00700804已完成不适用

Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?

USDA Grand Forks Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2003年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Calcium Absorption

研究概览

简要总结

The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism.

详细描述

This study tests the effects of dietary protein and calcium on calcium retention and indices of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2 Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass Index (weight in kilograms divided by height in meters squared)and randomly assigned to a high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group, and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7 weeks each. There is a 3-week "washout" between dietary periods, during which the subjects consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days by whole body scintillation counting. In addition to Calcium retention, other endpoints include urinary indices of acid excretion and urine serum indices of bone resorption.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • at least 3 years since last menses
  • bone mineral density equal to or greater than 2.5 standard deviations from average bone mineral density for young adults,
  • body mass index equal to or less than 35 kilograms/meter squared

排除标准

  • taking prescription medication other than hormone replacement therapy

研究组 & 干预措施

High Calcium Diet

Experimental

干预措施: High Protein Diet (Behavioral)

Low Calcium Diet

Experimental

干预措施: Low Protein Diet (Behavioral)

结局指标

主要结局

Calcium Absorption

时间窗: 17 weeks

Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time

次要结局

  • Serum Insulin-like Growth Factor 1 (IGF-1)(7 weeks)

研究者

发起方
USDA Grand Forks Human Nutrition Research Center
申办方类型
Fed
责任方
Sponsor

研究点 (2)

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