- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT03337971
Nutritional Supplement and Bone Health in Post-Menopausal Women (MBPS)
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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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;
- Arrive @ 17:00h with overnight bag;
- Empty bladder and then provide and retain urine samples for the duration of the stay (assisted collection by researchers);
- Consume a standardised evening meal (pre-prepared by the research dietitian) and then relax reading/watching films etc;
- 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;
- Further blood draws (5ml) will be taken at 22:00h, 2300h, 2400h,0100h and 0200h and the cannula withdrawn;
- At 22:00h consume either placebo control (PLACEBO) (day 1) OR supplement (MBPM)(day 2) - or vice versa - in randomised order.
- Retire to bedroom;
- 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);
- Repeat from 2 above to end of 2nd day.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Co Limerick
-
Limerick, Co Limerick, Ierland
- Werving
- University of Limerick
-
Contact:
- Philip Jakeman, PhD
- Telefoonnummer: 2800 +35361202800
- E-mail: phil.jakeman@ul.ie
-
Contact:
- Catherine Norton, PhD
- Telefoonnummer: 4780 +35361204780
- E-mail: catherine.norton@ul.ie
-
Onderonderzoeker:
- Catherine Norton, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Placebo-vergelijker: 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
|
Actieve vergelijker: 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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Bone turnover
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Change in regulator of bone metabolism - PTH
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IP2016_0476 (Ander subsidie-/financieringsnummer: Enterprise Ireland)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Botten en botten
-
Swansea UniversityVoltooidA Bite of ACT' (BOA) Acceptance and Commitment Therapy Online cursus psycho-educatie | Een wachtlijstcontroleVerenigd Koninkrijk
-
University of SheffieldMid Yorkshire Hospitals NHS TrustIngetrokkenObesitas, Acceptance and Commitment Therapy, Weight Management ServiceVerenigd Koninkrijk
-
Bambino Gesù Hospital and Research InstituteVoltooidErnstige pediatrische obesitas (BMI > 97° pc -Volgens Centers for Disease Control and Prevention BMI Charts-) | Veranderde leverfunctietesten | Glykemische intolerantieItalië
-
Alexandria UniversityVoltooidAcceptance and Commitment Therapy, geestelijke gezondheid, cognitieve stoornissen, colorectale kankerEgypte
Klinische onderzoeken op PLACEBO
-
SamA Pharmaceutical Co., LtdOnbekendAcute bronchitis | Acute bovenste luchtweginfectieKorea, republiek van
-
National Institute on Drug Abuse (NIDA)VoltooidCannabisgebruikVerenigde Staten
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyVoltooidMannelijke proefpersonen met diabetes type II (T2DM)Duitsland
-
Heptares Therapeutics LimitedVoltooidFarmacokinetiek | Veiligheid problemenVerenigd Koninkrijk
-
Texas A&M UniversityNutraboltVoltooidGlucose and Insulin Response
-
Soroka University Medical CenterVoltooid
-
Regado Biosciences, Inc.VoltooidGezonde vrijwilligerVerenigde Staten
-
Longeveron Inc.BeëindigdHypoplastisch linkerhartsyndroomVerenigde Staten
-
ItalfarmacoVoltooidBecker spierdystrofieNederland, Italië