- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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- Further blood draws (5ml) will be taken at 22:00h, 2300h, 2400h,0100h and 0200h and the cannula withdrawn;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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Co Limerick
-
Limerick, Co Limerick, Irlande
- Recrutement
- University of Limerick
-
Contact:
- Philip Jakeman, PhD
- Numéro de téléphone: 2800 +35361202800
- E-mail: phil.jakeman@ul.ie
-
Contact:
- Catherine Norton, PhD
- Numéro de téléphone: 4780 +35361204780
- E-mail: catherine.norton@ul.ie
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Sous-enquêteur:
- Catherine Norton, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Comparateur placebo: 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
|
Comparateur actif: 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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Bone turnover
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change in regulator of bone metabolism - PTH
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IP2016_0476 (Autre subvention/numéro de financement: Enterprise Ireland)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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