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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.
Full description
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.
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Inclusion criteria
Healthy as assessed by the
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.
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Primary purpose
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Interventional model
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12 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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