Family Milk Product Two-year Dose-response Study to Enhance Bone Health

NCT02236871 | Completed

• 1 other identifier: HW-14-03
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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 bone mineral density (BMD) are the best population health strategies in the primary prevention of osteoporosis. Diet and activity are key lifestyle factors in the primary prevention of osteoporosis as recognized in Canada's Food and Activity Guides. Dietary Reference Intakes are evidence-based regarding nutrition and bone health with a focus on calcium and vitamin D; yet the Food Guide and health behaviors are reliant on actual foods. The number of recommended servings of milk and alternatives varies by age with average intakes estimated to be below targets for all Canadians \> 9 y of age. This is especially concerning during development of PBM. Therefore, the global objective is to generate high-level evidence that dietary intervention with milk and milk products will enhance PBM in young men and women and maintenance of BMD in their parents. The primary objective is to demonstrate in healthy young men and women (14-18.9 y at baseline) with habitually low usual milk and milk product intakes that intervention with greater milk and milk product consumption improves lumbar spine BMD in a dose-response manner over 2 y (while accounting for body size, physical activity, demographics and age). Healthy young men and women will be recruited and screened for usual intake of milk and milk products. Those with low intakes \< 2 servings of milk or milk products will be randomized (stratified by sex and age) to 1 of 3 groups for the RCT (n=10090/group): maintain usual low intakes (\<1 serving), improved intakes (average of 2 servings/d) or recommended intakes (≥3 servings/d) of milk and milk products. A manualized motivational interviewing framework will be used for the interventions. Those meeting recommendations at screening will form a longitudinal cohort for 2 y. Key measurements include baseline and yearly assessment of BMD at multiple sites plus interim assessment of general health, anthropometry, dietary intakes, physical activity and biomarkers of calcium homeostasis; and in the young adults bone metabolism.

Conditions

Healthy

Keywords

Adolescents; Dairy; Bone

Outcome Measures

Primary Outcomes (1)

• Change in lumbar spine BMD (g/cm2) at 2 years.

  To examine in healthy young men and women (14-18.9 y at baseline) with habitually low usual milk and milk product intakes (\<1 serving/d) whether intervention with greater milk and milk product consumption improves lumbar spine (LS) BMD at 2 years in a dose-response manner.

  up to 2 years

Secondary Outcomes (5)

• Change in calcium homeostasis at 2 years.

  up to 2 years

• Change in whole body BMD (g/cm2) at 2 years

  up to 2 years

• Change in total hip BMD (g/cm2) at 2 years.

  up to 2 years

• Change in distal forearm BMD (g/cm2) at 2 years.

  up to 2 years

• Change in femoral neck BMD (g/cm2) at 2 years.

  up to 2 years

Study Arms (3)

Control

NO INTERVENTION

Maintain current milk and milk product intakes.

2 servings

ACTIVE COMPARATOR

Participants will be asked to consume 1 milk (250 ml) plus a yogurt (100-175 g) or cheese (up to 50 g) to reach an average of 2 servings of milk or milk products/d.

Behavioral: 2 servings

4 servings

ACTIVE COMPARATOR

Participants will be asked to consume recommended servings of milk or milk products/d for their age, so they will receive 1 milk (250 ml), a yogurt (175 g) and cheese (50 g) or more. This would provide ≥ 3 servings/d.

Behavioral: 4 servings

Interventions

2 servings BEHAVIORAL

Participants will receive motivational counseling to help the improve milk and milk product intakes to 2 servings per day.

2 servings

4 servings BEHAVIORAL

Participants will receive motivational counseling to help them increase their milk and milk product intake to 4 servings per day.

4 servings

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead
• Dairy Farmers of Canada: collaborator

Study Sites (1)

Mary Emily Clinical Nutrition Research Unit

Sainte-Anne-de-Bellevue, Quebec, H9X2E3, Canada

Location

Related Links

• Research site website

Study Officials

• Hope A Weiler, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 4, 2014
• First Posted: September 11, 2014
• Study Start: May 1, 2014
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CA (1)