Intake of Dietary Vitamin D and K From Tailor-made Atlantic Salmon and Bone Health - A Randomized Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Osteocalcin
研究概览
简要总结
The aims of this study were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status, as well as body composition and bone mineral density. The 122 healthy postmenopausal women included in this 12 weeks intervention study were randomized into four groups: three salmon groups (with three different vitamin D3/vitamin K1 combinations) and one tablet group (vitamin D and Calcium).
详细描述
Suboptimal vitamin D status is common among humans, and might have a negative impact on bone health. Fatty fish, including Atlantic salmon, is an important dietary vitamin D source. However, due to a considerable change in fish feed composition, the contribution of vitamin D from salmon fillet has been reduced. The aims were to investigate how intake of tailor-made salmon affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density (BMD). The 122 healthy postmenopausal women (median 55 years) included in this 12 weeks intervention study were randomized into four groups: three salmon groups (150 grams/two times/week) and one tablet group (800IU vitamin D and 1000 mg Calcium/day). The salmon groups also received calcium supplements (1000 mg/d). The salmon had three different vitamin D3/vitamin K1 combinations: high D3 + high K1, low D3 + high K1, or high D3 + low K1.
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
- 50 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal women
- •Caucasian ethnicity
- •Age range 50-65 years
- •Having postmenopausal age of at least one year
排除标准
- •Osteoporotic fractures
- •Medical treatment for osteoporosis
- •Warfarin treatment
- •Creatinine above or below normal range
- •Hypervitaminosis D
- •Malabsorption syndrome
- •Inflammatory bowel disease
- •Inflammatory rheumatic diseases
- •Women who had planned to go away on holiday during the intervention could not participate
结局指标
主要结局
Osteocalcin
时间窗: 3 months
Serum (ng/ml)
Carboxylated osteocalcine (GLA)
时间窗: 3 months
Serum (ng/ml)
N-telopeptides/creatinine
时间窗: 3 months
Urinary (mmol/l)
GLU/GLA-ratio
时间窗: 3 months
Ratio of undercarboxylated osteocalcin and carboxylated osteocalcine
Deoxypyridinoline/creatinine
时间窗: 3 months
Urinary (mmol/l)
Undercarboxylated osteocalcin (GLU)
时间窗: 3 months
Serum (ng/ml)
Bone-specific alkaline phosphatase
时间窗: 3 months
Serum (µg/l)
次要结局
- 25-hyroxyvitamin D(3 months)
- Bone mineral density(3 months)
- Body composition(3 months)
- Docosahexaenoic acids(3 months)
- Omega-3 index(3 months)
- Eicosapentaenoic acids(3 months)
研究者
Jannike Øyen
Jannike Øyen, PhD
National Institute of Nutrition and Seafood Research, Norway