The Effect of Nutritional Intervention on Bone Metabolism as Assessed by 41Ca and Modeling; Proof of Concept
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Osteoporosis
- 发起方
- TNO
- 入组人数
- 12
- 主要终点
- urinary 41calcium excretion
- 状态
- 已完成
- 最后更新
- 12年前
概览
简要总结
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.
详细描述
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.
研究者
Henk FJ Hendriks
PhD
TNO
入排标准
入选标准
- •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
排除标准
- •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
结局指标
主要结局
urinary 41calcium excretion
时间窗: 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.
次要结局
- commonly accepted biomarkers for bone metabolism(on study day numbers: 148, 183, 218, 253, 288)