- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01910142
Effect of Nutrition on Bone Metabolism as Assessed by 41Ca
26. juli 2013 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
12
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 68 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / 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 komparator: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
urinary 41calcium excretion
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
commonly accepted biomarkers for bone metabolism
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Gertruud C Bakker, PhD, TNO
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2008
Primær fullføring (Faktiske)
1. august 2009
Studiet fullført (Faktiske)
1. august 2009
Datoer for studieregistrering
Først innsendt
9. april 2010
Først innsendt som oppfylte QC-kriteriene
26. juli 2013
Først lagt ut (Anslag)
29. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
29. juli 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. juli 2013
Sist bekreftet
1. juli 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Metabolske sykdommer
- Muskel- og skjelettsykdommer
- Beinsykdommer
- Bensykdommer, metabolske
- Osteoporose
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Fibrinmodulerende midler
- Mikronæringsstoffer
- Vitaminer
- Kalsiumregulerende hormoner og midler
- Antifibrinolytiske midler
- Hemostatikk
- Koagulanter
- Vitamin K
- Kalsium
Andre studie-ID-numre
- 8145
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