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Effect of Nutrition on Bone Metabolism as Assessed by 41Ca

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vitamin K
calcium
Sponsored by
TNO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Osteoporosis focused on measuring bone metabolism

Eligibility Criteria

50 Years - 68 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy as assessed by the

    • health and lifestyle questionnaire,
    • physical examination
    • results of the pre-study laboratory tests
  2. Females aged 50-68 years at Day 01 of the study
  3. Relatively low calcium intake as assessed by dairy intake questionnaire
  4. Body Mass Index (BMI) < 30 kg/m2
  5. Postmenopausal as confirmed by Follicle stimulating hormone (FSH) and oestradiol (E2) blood levels (FSH > 40IU/L, E2 < 70 pg/mL)
  6. Normal Dutch eating habits
  7. Voluntary participation
  8. Having given written informed consent
  9. Willing to comply with the study procedures
  10. Appropriate veins for blood sampling/cannula insertion according to TNO
  11. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
  12. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.

Exclusion Criteria:

  1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
  2. 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
  3. Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension and gastrointestinal disease
  4. Prescribed medication, including hormone replacement therapy (within 6 months before start of the study) and anticoagulant medication.
  5. Reported intolerance for dairy products
  6. Not willing to stop the use of Boerenkarnemelk and cheese of the following Dutch brands: Emmenthaler, Gruyere, Leer/Maasdammer
  7. Alcohol consumption > 21 units/week
  8. Not willing to stop use of supplements containing minerals or vitamins
  9. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
  10. Reported slimming or medically prescribed diet
  11. Reported vegan, vegetarian or macrobiotic
  12. Recent blood donation (<1 month prior to the start of the study)
  13. Not willing to give up blood donation during the study.
  14. Personnel of TNO Quality of Life, their partner and their first and second degree relatives
  15. Not having a general practitioner
  16. 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    calcium supplement with vitamin K

    calcium supplement without vitamin K

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    urinary 41calcium excretion
    Urine is collected for measurement of 41Ca. The concentration change of 41Ca during the intervention period indicates the efficacy of the intervention.

    Secondary Outcome Measures

    commonly accepted biomarkers for bone metabolism
    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.

    Full Information

    First Posted
    April 9, 2010
    Last Updated
    July 26, 2013
    Sponsor
    TNO
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01910142
    Brief Title
    Effect of Nutrition on Bone Metabolism as Assessed by 41Ca
    Official Title
    The Effect of Nutritional Intervention on Bone Metabolism as Assessed by 41Ca and Modeling; Proof of Concept
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2008 (undefined)
    Primary Completion Date
    August 2009 (Actual)
    Study Completion Date
    August 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    TNO

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 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.
    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoporosis
    Keywords
    bone metabolism

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    calcium supplement with vitamin K
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    calcium supplement without vitamin K
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    vitamin K
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    calcium
    Primary Outcome Measure Information:
    Title
    urinary 41calcium excretion
    Description
    Urine is collected for measurement of 41Ca. The concentration change of 41Ca during the intervention period indicates the efficacy of the intervention.
    Time Frame
    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
    Secondary Outcome Measure Information:
    Title
    commonly accepted biomarkers for bone metabolism
    Description
    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.
    Time Frame
    on study day numbers: 148, 183, 218, 253, 288

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    68 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gertruud C Bakker, PhD
    Organizational Affiliation
    TNO
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Effect of Nutrition on Bone Metabolism as Assessed by 41Ca

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