Status:
COMPLETED
Family Milk Product Two-year Dose-response Study to Enhance Bone Health
Lead Sponsor:
McGill University
Collaborating Sponsors:
Dairy Farmers of Canada
Conditions:
Healthy
Eligibility:
All Genders
14-18 years
Phase:
NA
Brief Summary
The final stages in the development of peak bone mass (PBM) reside in late adolescence or early adulthood and are critical in the achievement of bone health. Optimization of PBM and maintenance of bon...
Detailed Description
Rationale: The final stages in development of peak bone mass (PBM) take place in late adolescence or early adulthood and are vital for attaining optimal bone health. The variation in bone mineral den...
Eligibility Criteria
Inclusion
- 14 to 18.9 y of age at onset of the intervention
- reside with their parents
- consume \< 1 serving/d of milk and milk products
- \> 2 y post-menarche
- non smoker
- not routinely taking prescribed oral medication including oral/dermal
- healthy body mass index (BMI) defined as ± 1SD of 50% percentile WHO curves
- normal bone mass for age/sex
- adequate vitamin D status (\>30 nmol/L 25(OH)D)
- no anemia
- receptive to stop any nutritional supplements 2 weeks prior to and during the study.
Exclusion
- Any known chronic disease with exception of mild asthma (\<500 µg budesonide) that does not affect BMD Z-scores
- Anaemic (defined as Hg \<13.5 g/dL in males and \<12.0 g/dL in females for their age group).
- Known allergies or aversions to milk and milk products
- Anticipating becoming pregnant or a moving distant from Montreal or from family home in the next 2 y.
- Have preference for non-dairy alternatives
- consume ≥2 alcoholic beverages/day
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT02236871
Start Date
May 1 2014
End Date
December 20 2019
Last Update
February 5 2020
Active Locations (1)
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1
Mary Emily Clinical Nutrition Research Unit
Sainte-Anne-de-Bellevue, Quebec, Canada, H9X2E3