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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:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Bone and Bones Osteoporosis Risk Osteoporosis, Postmenopausal Dietary Supplement: PLACEBO Dietary Supplement: MBPM

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
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
Official Title: 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
Actual Study Start Date : October 3, 2017
Estimated Primary Completion Date : December 28, 2018
Estimated Study Completion Date : April 4, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

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
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

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337971


Contacts
Contact: Philip M Jakeman, PhD +35361202800 ext 2800 phil.jakeman@ul.ie
Contact: Mary Clarke-Moloney, BSc +35361204230 ext 4230 Mary.ClarkMoloney@ul.ie

Locations
Ireland
University of Limerick Recruiting
Limerick, Co Limerick, Ireland
Contact: Philip Jakeman, PhD    +35361202800 ext 2800    phil.jakeman@ul.ie   
Contact: Catherine Norton, PhD    +35361204780 ext 4780    catherine.norton@ul.ie   
Principal Investigator: Philip Jakeman, PhD         
Sub-Investigator: Catherine Norton, PhD         
Sponsors and Collaborators
University of Limerick
Dairygold Cooperative Society Ltd
Investigators
Principal Investigator: Philip M Jakeman, PhD University of Limerick
  Study Documents (Full-Text)

Documents provided by Phil Jakeman, University of Limerick:
Statistical Analysis Plan  [PDF] November 2, 2017
Study Protocol and Informed Consent Form  [PDF] November 6, 2017

More Information

Additional Information:
Responsible Party: Phil Jakeman, Principal Investigator, University of Limerick
ClinicalTrials.gov Identifier: NCT03337971     History of Changes
Other Study ID Numbers: IP2016_0476
IP2016_0476 ( Other Grant/Funding Number: Enterprise Ireland )
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Phil Jakeman, University of Limerick:
Post-menopausal
Osteoporosis
Bone Turnover Markers
Dairy Products

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases