FAMILY (FAmily MILk Product Two-Year) Dose-response Study to Enhance Bone Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Change in lumbar spine BMD (g/cm2) at 2 years.
研究概览
简要总结
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.
详细描述
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 density (BMD) at the time of PBM is similar with aging, suggesting that the benefits of efforts to enhance BMD early will later be realized with aging. Therefore, optimization of PBM and maintenance of BMD are thus the best population health strategies in the primary prevention of osteoporosis and reduction in risk of fracture.
Osteoporosis is a bone disease that results in low bone mass and reduced bone tissue, thereby, increasing bone fragility. The World Health Organization (WHO) defines osteoporosis as a BMD value of 2.5 SD or more below a reference population specific PBM and is associated with an elevated risk of fracture. Diet and activity are key lifestyle factors in the primary prevention of osteoporosis. The number of recommended servings of milk and alternatives varies by age with actual intakes estimated to be below targets for all Canadians 9 y of age and older. For example, young men and women, aged 15 to 18.9 years, should consume 3 to 4 servings/day of milk and alternatives according to Canada's Food Guide, however, in reality, adherence to food guide recommendations is not the norm for Canadians with intakes as low as 1.36 servings in males and 1.24 servings in females on average.
If Canadians are to realize the benefits of meeting Canada's Food Guide recommended servings for the Milk and Alternates Food Group, at least in terms of meeting nutrient intake recommendations if not bone health outcomes, behavior change will be necessary. There is some evidence that increasing milk and/or milk products is a proven approach to achieving calcium intake with benefits to bone health. From a professional counselling perspective, motivational interviewing techniques have been useful in stimulating and sustaining behavior change given its success in triggering changes in a number of health behaviors.
Besides counseling, research suggests that the family environment or social support system predict ability to make behavior change. Healthy physical activity and nutrition are reliant upon parental behaviors, beliefs and perceptions and may also include practical parental support for modeling healthy food intake or accessibility to healthy food at home. Therefore, studying the role of parents in increasing their children's dairy intake will be of an added-value to our study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in lumbar spine BMD (g/cm2) at 2 years.
时间窗: up to 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.
次要结局
- 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 distal forearm 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 femoral neck BMD (g/cm2) at 2 years.(up to 2 years)
研究者
Hope Weiler
Associate Professor
McGill University