Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile (MEDA)
2013年3月22日 更新者：AAstrup、University of Copenhagen
Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile in Urine and Plasma in Overweight Adults
The purpose of this randomized, controlled, cross over single meal study is to investigate the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for their intake.
The results from this project will increase our knowledge about nutritional value of dairy proteins, which is necessary to decide whether dairy products can be recommended for prevention of weight related bone loss.
研究概览
研究类型
介入性
注册 (实际的)
17
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
-
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Frederiksberg C
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Copenhagen、Frederiksberg C、丹麦、1958
- Department of Human Nutrition, University of Copenhagen
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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
18年 至 50年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy males and females between 18 and 50 years
- BMI 25-40
Exclusion Criteria:
- Physical activity more than 10 hours weekly
- Smoking
- Diagnosed osteoporosis in at least one parent
- Dietary supplements and vitamin pills (during the study and 2 months before the start)
- Vegetarians and vegans
- Lactose intolerant
- Women who are pregnant, breastfeeding or post-menstrual
- Regular intake of medication
- Chronic diseases (including osteoporosis, cancer, diabetes, cardiovascular disease and mental disorders)
- Participation in other clinical trials that could affect the test results
- Donation of blod within 3 months before intervention start
- Hypersensitivity to paraaminobenzoic acid (PABA)
- Not able to comply with the procedures established by the Protocol
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：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Meal rich in dairy protein
|
Test meals with different protein types (dairy versus meat)
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实验性的：Meal rich in meat protein
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Test meals with different protein types (dairy versus meat)
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
serum C-terminal carboxy-terminal collagen crosslinks (CTX)
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
urine C-terminal carboxy-terminal collagen
大体时间：baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
|
serum osteocalcin (sOC)
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
serum tartrate-resistant acid phosphatase (s-TRAP)
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
urine deoxypyridinoline crosslink (uDPD)
大体时间：baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
|
plasma metabolites for metabolomics analyses
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
urine metabolites for metabolomics analyses
大体时间：baseline 24-h urine samples, 24-h urine samples after the meal test, urine samples at 2-h and 4-h after the meal test and urine samples from 4-h to 24-h, all at both visits
|
baseline 24-h urine samples, 24-h urine samples after the meal test, urine samples at 2-h and 4-h after the meal test and urine samples from 4-h to 24-h, all at both visits
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
serum insulin-growth factor-1 (IGF-1)
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
serum insulin-growth factor binding-protein-3 (IGFBP-3)
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
serum insulin
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
serum glucose
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
serum glukagon-like peptide-1 (GLP-1)
大体时间：at 0, 30, 60, 120, 180 and 240 min at both visits
|
at 0, 30, 60, 120, 180 and 240 min at both visits
|
|
urinary PABA
大体时间：baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
|
urinary creatinin
大体时间：baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
|
urinary biobank
大体时间：baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
baseline 24-h urine samples and 24-h urine samples after the meal test at both visits
|
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plasma biobank
大体时间：at 0, 30, 60, 90, 120, 180 and 240 min at both visits
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at 0, 30, 60, 90, 120, 180 and 240 min at both visits
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
weight
大体时间：at baseline at both visits
|
at baseline at both visits
|
|
height
大体时间：at baseline at the first visit
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at baseline at the first visit
|
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。
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12月1日
初级完成 (实际的)
2013年2月1日
研究完成 (实际的)
2013年2月1日
研究注册日期
首次提交
2013年1月15日
首先提交符合 QC 标准的
2013年1月22日
首次发布 (估计)
2013年1月23日
研究记录更新
最后更新发布 (估计)
2013年3月25日
上次提交的符合 QC 标准的更新
2013年3月22日
最后验证
2013年3月1日
更多信息
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.