Status:
COMPLETED
Effect of Nutrition on Bone Metabolism as Assessed by 41Ca
Lead Sponsor:
TNO
Conditions:
Osteoporosis
Eligibility:
FEMALE
50-68 years
Phase:
NA
Brief Summary
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 purp...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01910142
Start Date
November 1 2008
End Date
August 1 2009
Last Update
July 29 2013
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