Clinical trial NCT03337971: Nutritional Supplement and Bone Health in Post-Menopausal Women
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone and Bones
Osteoporosis Risk
Osteoporosis, Postmenopausal
Keywords: Post-menopausal
Osteoporosis
Bone Turnover Markers
Dairy Products
Lead sponsor: University of Limerick
Sponsor class: OTHER
Collaborators: name: Dairygold Cooperative Society Ltd
First posted: 2017-11-09
Enrollment: 16
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A block randomised, cross-over design receiving either a milk-based protein supplement (MBPS) or isoenergetic (corn starch) placebo control (PLACEBO).
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Bone turnover
timeFrame: Pre-ingestion and1,2,3 and 4hours post-ingestion (serum) and Pre-ingestion to +24hour post-ingestion (urine)
Secondary outcomes:
measure: Change in regulator of bone metabolism - PTH
timeFrame: Pre-ingestion,1,2,3 and 4hours post-ingestion
measure: Change in regulator of bone metabolism - RANKL
timeFrame: Pre-ingestion,1,2,3 and 4hours post-ingestion
measure: Change in regulator of bone metabolism - OPG
timeFrame: Pre-ingestion,1,2,3 and 4hours post-ingestion
measure: Incretin peptide (GIP)
timeFrame: Pre-ingestion,1,2,3 and 4hours post-ingestion
measure: Incretin peptide (GLP-1)
timeFrame: Pre-ingestion,1,2,3 and 4hours post-ingestion
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University of Limerick
state: Co Limerick
Study officials:
affiliation: University of Limerick
name: Philip M Jakeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: