An interventional study of PLACEBO and MBPM in Bone and Bones, Osteoporosis Risk and Osteoporosis, Postmenopausal, sponsored by University of Limerick. Completed at 1 site in Ireland. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-31.
Sponsored by University of Limerick · Not applicable, Interventional, and Basic science
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.
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;
337 studies on the registry are indexed under Osteoporosis, Postmenopausal; 29 are open to participants now.
This study's enrollment of 16 is below the median of 110 across 265 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →University of Limerick is the lead sponsor of 60 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
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
Dietary Supplement: PLACEBO
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
Dietary Supplement: MBPM
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
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
Bone turnover
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
Time frame: Pre-ingestion and1,2,3 and 4hours post-ingestion (serum) and Pre-ingestion to +24hour post-ingestion (urine)
Change in regulator of bone metabolism - PTH
The magnitude and time course of the acute change (0-4h) in serum parathyroid hormone (PTH) measured in pmol/L
Time frame: Pre-ingestion,1,2,3 and 4hours post-ingestion
Change in regulator of bone metabolism - RANKL
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
Time frame: Pre-ingestion,1,2,3 and 4hours post-ingestion
Change in regulator of bone metabolism - OPG
The magnitude and time course of the acute change (0-4h) in serum receptor activator of the osteoprotegerin (OPG) measured in pg/mL
Time frame: Pre-ingestion,1,2,3 and 4hours post-ingestion
Incretin peptide (GIP)
The magnitude and time course of the acute change (0-4h) in enterogastric peptide glucose-dependent insulinotropic peptide (GIP1-42) measured in pg/mL
Time frame: Pre-ingestion,1,2,3 and 4hours post-ingestion
Incretin peptide (GLP-1)
The magnitude and time course of the acute change (0-4h) in enterogastric glucagon-like peptide-1 (GLP-17-36) measured in pg/mL
Time frame: Pre-ingestion,1,2,3 and 4hours post-ingestion
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Osteoporosis, Postmenopausal →
University of Limerick