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

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ClinicalTrials.gov Identifier: NCT03337971
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Dairygold Cooperative Society Ltd
Information provided by (Responsible Party):
Phil Jakeman, University of Limerick

October 12, 2017
November 9, 2017
November 9, 2017
October 3, 2017
December 28, 2018   (Final data collection date for primary outcome measure)
Bone turnover [ Time Frame: 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
Same as current
No Changes Posted
  • Change in regulator of bone metabolism - PTH [ Time Frame: 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
  • Change in regulator of bone metabolism - RANKL [ Time Frame: 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
  • Change in regulator of bone metabolism - OPG [ Time Frame: 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
  • Incretin peptide (GIP) [ Time Frame: 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
  • Incretin peptide (GLP-1) [ Time Frame: 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
Same as current
Not Provided
Not Provided
 
Nutritional Supplement and Bone Health in Post-Menopausal Women
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.

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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
A block randomised, cross-over design receiving either a milk-based protein supplement (MBPS) or isoenergetic (corn starch) placebo control (PLACEBO).
Masking: Single (Participant)
Masking Description:
Single blind (participant only)
Primary Purpose: Basic Science
  • Bone and Bones
  • Osteoporosis Risk
  • Osteoporosis, Postmenopausal
  • Dietary Supplement: PLACEBO
    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
  • Dietary Supplement: MBPM
    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
  • Placebo Comparator: 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

    Intervention: Dietary Supplement: PLACEBO
  • Active Comparator: 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

    Intervention: Dietary Supplement: MBPM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
16
Same as current
April 4, 2019
December 28, 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: Female
50 Years to 70 Years   (Adult, Older Adult)
Yes
Contact: Philip M Jakeman, PhD +35361202800 ext 2800 phil.jakeman@ul.ie
Contact: Mary Clarke-Moloney, BSc +35361204230 ext 4230 Mary.ClarkMoloney@ul.ie
Ireland
 
 
NCT03337971
IP2016_0476
IP2016_0476 ( Other Grant/Funding Number: Enterprise Ireland )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Phil Jakeman, University of Limerick
University of Limerick
Dairygold Cooperative Society Ltd
Principal Investigator: Philip M Jakeman, PhD University of Limerick
University of Limerick
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP