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Effect of Nutrition on Bone Metabolism as Assessed by 41Ca

26 juli 2013 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

12

Fas

  • Inte tillämpbar

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

50 år till 68 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Kvinna

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.
Placebo-jämförare: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
urinary 41calcium excretion
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
commonly accepted biomarkers for bone metabolism
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

TNO

Utredare

  • Huvudutredare: Gertruud C Bakker, PhD, TNO

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 november 2008

Primärt slutförande (Faktisk)

1 augusti 2009

Avslutad studie (Faktisk)

1 augusti 2009

Studieregistreringsdatum

Först inskickad

9 april 2010

Först inskickad som uppfyllde QC-kriterierna

26 juli 2013

Första postat (Uppskatta)

29 juli 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

29 juli 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 juli 2013

Senast verifierad

1 juli 2013

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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