Nutritional Supplement and Bone Health in Post-Menopausal Women

NCT03337971 | Completed DMC

• 1 other identifier: IP2016_0476
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone and Bones; Osteoporosis Risk; Osteoporosis, Postmenopausal

Keywords

Post-menopausal; Osteoporosis; Bone Turnover Markers; Dairy Products

Outcome Measures

Primary Outcomes (1)

• 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

  Pre-ingestion and1,2,3 and 4hours post-ingestion (serum) and Pre-ingestion to +24hour post-ingestion (urine)

Secondary Outcomes (5)

• Change in regulator of bone metabolism - PTH

  Pre-ingestion,1,2,3 and 4hours post-ingestion

• Change in regulator of bone metabolism - RANKL

  Pre-ingestion,1,2,3 and 4hours post-ingestion

• Change in regulator of bone metabolism - OPG

  Pre-ingestion,1,2,3 and 4hours post-ingestion

• Incretin peptide (GIP)

  Pre-ingestion,1,2,3 and 4hours post-ingestion

• Incretin peptide (GLP-1)

  Pre-ingestion,1,2,3 and 4hours post-ingestion

Study Arms (2)

PLACEBO

PLACEBO COMPARATOR

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

Milk-based protein matrix

ACTIVE COMPARATOR

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

Interventions

PLACEBO DIETARY_SUPPLEMENT

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

PLACEBO

MBPM DIETARY_SUPPLEMENT

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

Milk-based protein matrix

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Intolerance to dairy-based food products

Sponsors & Collaborators

• University of Limerick: lead
• Dairygold Cooperative Society Ltd: collaborator

Study Sites (1)

University of Limerick

Limerick, Co Limerick, Ireland

Location

Related Links

• Center for Inreventions in Inflammation Infection and Immunity

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Philip M Jakeman, PhD

  University of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blind (participant only)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A block randomised, cross-over design receiving either a milk-based protein supplement (MBPS) or isoenergetic (corn starch) placebo control (PLACEBO).

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 9, 2017
• Study Start: October 3, 2017
• Primary Completion: December 28, 2018
• Study Completion: June 23, 2019
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)