Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Nutritional Supplement and Bone Health in Post-Menopausal Women (MBPS)

6. november 2017 oppdatert av: Phil Jakeman, University of Limerick

Evaluation of a Milk-Based Nutritional Supplement to Modify Diurnal Rates of Bone Turnover and Effect a Positive Change in Bone Health in Post-Menopausal Women at Risk of Osteoporosis

The process of bone remodeling exhibits pronounced diurnal pattern that is important for bone health. A balanced rate of bone resorption is required to maintain bone health, a balance that can be disturbed during the lifecycle to effect net rate of formation (as occurs during growth and development to adulthood) or net resorption (as occurs, for example, during the menopause).The research to be undertaken investigates the pluripotent effect of dairy-based products on the regulation of the diurnal process of bone metabolism in post-menopausal women at risk of osteoporosis.

Studieoversikt

Detaljert beskrivelse

Study Design: A block randomised, cross-over design of 24h rates of bone turnover in healthy, post-menopausal women with osteopenia receiving either a milk-based protein supplement (MBPS) or isoenergetic placebo control (PLACEBO).

Participants: 16 Post-menopausal women with osteopenia as determined by site-specific bone mineral density BMD (DXA) diagnosed and screened by a clinician and for dietary intake of calcium and Vit D by a clinical dietitian.

Subject screening (clinical examination) and dietary intake of calcium and Vit D (by food frequency questionnaire) will precede the experimental protocol.

Experimental protocol and data collection:

Subjects will attend for a 2 day and 2 night (overnight) residence equipped to conduct residential human trials.

The subjects' programmed protocol is as follows;

  1. Arrive @ 17:00h with overnight bag;
  2. Empty bladder and then provide and retain urine samples for the duration of the stay (assisted collection by researchers);
  3. Consume a standardised evening meal (pre-prepared by the research dietitian) and then relax reading/watching films etc;
  4. At 20:00h a research nurse will insert a cannula into a superficial arm vein and a blood draw (5ml) will be taken and processed for later analysis;
  5. Further blood draws (5ml) will be taken at 22:00h, 2300h, 2400h,0100h and 0200h and the cannula withdrawn;
  6. At 22:00h consume either placebo control (PLACEBO) (day 1) OR supplement (MBPM)(day 2) - or vice versa - in randomised order.
  7. Retire to bedroom;
  8. Consume a standardised breakfast and lunch (pre-prepared by the research dietitian) whilst living in and around the University grounds (i.e. in close proximity to ensure 24h urine collection is complete);
  9. Repeat from 2 above to end of 2nd day.

Studietype

Intervensjonell

Registrering (Forventet)

16

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Co Limerick
      • Limerick, Co Limerick, Irland
        • Rekruttering
        • University of Limerick
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Catherine Norton, PhD

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 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

Post-menopausal women aged 50-70y. Assessed by site-specific BMD to be osteopenic. Assessed by clinical screen to be otherwise healthy and free from other illness or current medication likely to influence the study outcome.

Exclusion Criteria:

Intolerance to dairy-based food products

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: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: PLACEBO

Intervention: Dietary Supplement: PLACEBO A group of subjects ingesting a liquid beverage (0.3g per kg body mass ; 1.2kcal/kg body mass) at 10:00pm, 3h post-absorptive of a standardised evening meal.

Samples for the measurement of biomarkers of change in the rate of bone turnover appearing in the blood to be collected for the immediate 4h, and excreted in urine, 24h post-ingestion

A food-grade proprietary product containing corn starch in powder form, flavoured and instantised to be dissolved in water. Supplied by Dairygold Ingredients, Mitchelstown, Co Cork, Ireland
Aktiv komparator: Milk-based protein matrix

Intervention: Dietary Supplement: MBPM A group of subjects ingesting a liquid beverage (0.3g per kg body mass ; 1.2kcal/kg body mass) at 10:00pm, 3h post-absorptive of a standardised evening meal.

Samples for the measurement of biomarkers of change in the rate of bone turnover appearing in the blood to be collected for the immediate 4h, and excreted in urine, 24h post-ingestion

A food-grade proprietary product containing per 100g; milk protein (46.4%), carbohydrate (40.6%), fat (0.7%), Vitamin D (2ug); calcium (1840mg) in powder form, flavoured and instantised to be dissolved in water. Supplied by Dairygold Ingredients, Mitchelstown, Co Cork, Ireland

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bone turnover
Tidsramme: Pre-ingestion and1,2,3 and 4hours post-ingestion (serum) and Pre-ingestion to +24hour post-ingestion (urine)
A balance of the difference between the magnitude and time course of the acute change (0-4h) in serum C-terminal telopeptide of type 1 collagen (CTX) in ng/mL, a measure of bone resorption, and procollagen type 1 amino-terminal propeptide (P1NP) in ng/ml, a measure of bone formation and diurnal change in bone resorption measured by 24h urinary excretion of deoxypyridinoline (Dpd), a marker of bone resorption, normalised to creatinine. Units nmolDPD/mmolCr
Pre-ingestion and1,2,3 and 4hours post-ingestion (serum) and Pre-ingestion to +24hour post-ingestion (urine)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in regulator of bone metabolism - PTH
Tidsramme: Pre-ingestion,1,2,3 and 4hours post-ingestion
The magnitude and time course of the acute change (0-4h) in serum parathyroid hormone (PTH) measured in pmol/L
Pre-ingestion,1,2,3 and 4hours post-ingestion
Change in regulator of bone metabolism - RANKL
Tidsramme: Pre-ingestion,1,2,3 and 4hours post-ingestion
The magnitude and time course of the acute change (0-4h) in serum receptor activator of the nuclear factor κB ligand (RANKL) measured in ng/dL
Pre-ingestion,1,2,3 and 4hours post-ingestion
Change in regulator of bone metabolism - OPG
Tidsramme: Pre-ingestion,1,2,3 and 4hours post-ingestion
The magnitude and time course of the acute change (0-4h) in serum receptor activator of the osteoprotegerin (OPG) measured in pg/mL
Pre-ingestion,1,2,3 and 4hours post-ingestion
Incretin peptide (GIP)
Tidsramme: Pre-ingestion,1,2,3 and 4hours post-ingestion
The magnitude and time course of the acute change (0-4h) in enterogastric peptide glucose-dependent insulinotropic peptide (GIP1-42) measured in pg/mL
Pre-ingestion,1,2,3 and 4hours post-ingestion
Incretin peptide (GLP-1)
Tidsramme: Pre-ingestion,1,2,3 and 4hours post-ingestion
The magnitude and time course of the acute change (0-4h) in enterogastric glucagon-like peptide-1 (GLP-17-36) measured in pg/mL
Pre-ingestion,1,2,3 and 4hours post-ingestion

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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 (Faktiske)

3. oktober 2017

Primær fullføring (Forventet)

28. desember 2018

Studiet fullført (Forventet)

4. april 2019

Datoer for studieregistrering

Først innsendt

12. oktober 2017

Først innsendt som oppfylte QC-kriteriene

6. november 2017

Først lagt ut (Faktiske)

9. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. november 2017

Sist bekreftet

1. november 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IP2016_0476 (Annet stipend/finansieringsnummer: Enterprise Ireland)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Bone and Bones

Kliniske studier på PLACEBO

3
Abonnere