Effect of Nutrition on Bone Metabolism as Assessed by 41Ca
2013年7月26日 更新者:Henk FJ Hendriks、TNO
The Effect of Nutritional Intervention on Bone Metabolism as Assessed by 41Ca and Modeling; Proof of Concept
The present study aims to develop a technique based on a single dose of a calcium isotope, which enables to determine the effect of a nutritional intervention on bone calcium metabolism.
For this purpose nutritional interventions with calcium, vitamin D and vitamin K will be applied in postmenopausal women.
Treatment effects will be determined by the urinary excretion of the calcium isotope and related to classical bone markers.
研究概览
详细说明
In the present proposal a method is described that may enable studying the effect of nutrition on bone calcium turnover far more accurate, within a shorter time frame and therefore less intensive for the volunteers in clinical studies as compared to presently existing methods.
This method will enable screening for promising food concepts for combating osteoporosis within a relatively short time.
Recent developments show that use of the nuclide 41Calcium (41Ca) and measurement by accelerator mass spectrometry (AMS) has great potential in measuring effects on bone level within a relatively short period of time.
When introducing a diet change (intervention) the bone metabolism of calcium may change resulting in a changed 41Ca-signal in the urine.
So far a few medication studies with osteoporotic volunteers have been performed and it appears that this ultrahigh sensitive technique may also be applicable for nutrition studies in healthy volunteers.
研究类型
介入性
注册 (实际的)
12
阶段
- 不适用
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
50年 至 68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:
Healthy as assessed by the
- health and lifestyle questionnaire,
- physical examination
- results of the pre-study laboratory tests
- Females aged 50-68 years at Day 01 of the study
- Relatively low calcium intake as assessed by dairy intake questionnaire
- Body Mass Index (BMI) < 30 kg/m2
- Postmenopausal as confirmed by Follicle stimulating hormone (FSH) and oestradiol (E2) blood levels (FSH > 40IU/L, E2 < 70 pg/mL)
- Normal Dutch eating habits
- Voluntary participation
- Having given written informed consent
- Willing to comply with the study procedures
- Appropriate veins for blood sampling/cannula insertion according to TNO
- Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
Exclusion Criteria:
- Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension and gastrointestinal disease
- Prescribed medication, including hormone replacement therapy (within 6 months before start of the study) and anticoagulant medication.
- Reported intolerance for dairy products
- Not willing to stop the use of Boerenkarnemelk and cheese of the following Dutch brands: Emmenthaler, Gruyere, Leer/Maasdammer
- Alcohol consumption > 21 units/week
- Not willing to stop use of supplements containing minerals or vitamins
- Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- Reported slimming or medically prescribed diet
- Reported vegan, vegetarian or macrobiotic
- Recent blood donation (<1 month prior to the start of the study)
- Not willing to give up blood donation during the study.
- Personnel of TNO Quality of Life, their partner and their first and second degree relatives
- Not having a general practitioner
- Not willing to accept information-transfer concerning participation in the study, or information regarding her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from her general practitioner.
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:基础科学
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:calcium supplement with vitamin K
Milk product supplying about 420 mg Ca and 7.5 μg vitamin D3 and 100 μg vitamin K.
Additional 200 mg calcium in the form of carbonate
|
A calcium product will be given either with or without vitamin K.
Each intervention will last for 5 weeks, each followed by a 5 week wash-out.
The first intervention will start about 4 months after inclusion and the single 41Ca bolus.
|
|
安慰剂比较:calcium supplement without vitamin K
Milk product supplying about 420 mg Ca and 7.5 μg vitamin D3. no vitamin K.
Additional 200 mg calcium in the form of carbonate
|
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 |
|---|---|---|
|
urinary 41calcium excretion
大体时间:on study day numbers: 36, 71, 106, 113, 120, 127, 134, 141, 148, 155, 162, 169, 176, 183, 190, 197, 204, 211, 218, 225, 232, 239, 246, 253, 260, 267, 274, 281, 288
|
Urine is collected for measurement of 41Ca.
The concentration change of 41Ca during the intervention period indicates the efficacy of the intervention.
|
on study day numbers: 36, 71, 106, 113, 120, 127, 134, 141, 148, 155, 162, 169, 176, 183, 190, 197, 204, 211, 218, 225, 232, 239, 246, 253, 260, 267, 274, 281, 288
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
commonly accepted biomarkers for bone metabolism
大体时间:on study day numbers: 148, 183, 218, 253, 288
|
Plasma osteocalcin and urinary deoxypyridinolin/creatinin ratio are measured as traditional markers for bone accretion and bone resorption respectively.
These are the most commonly used biomarkers for bone metabolism.
|
on study day numbers: 148, 183, 218, 253, 288
|
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。
赞助
调查人员
- 首席研究员:Gertruud C Bakker, PhD、TNO
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
2008年11月1日
初级完成 (实际的)
2009年8月1日
研究完成 (实际的)
2009年8月1日
研究注册日期
首次提交
2010年4月9日
首先提交符合 QC 标准的
2013年7月26日
首次发布 (估计)
2013年7月29日
研究记录更新
最后更新发布 (估计)
2013年7月29日
上次提交的符合 QC 标准的更新
2013年7月26日
最后验证
2013年7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.