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临床试验/NCT01478724
NCT01478724已完成1 期

Effects of Proteins Fraction Derived From Milk on Bone Mineral Density and Bone Metabolism in Healthy Postmenopausal Women

Soredab2 个研究点 分布在 1 个国家目标入组 291 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
291
试验地点
2
主要终点
lumbar spine bone mineral density

研究概览

简要总结

Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass and microarchitectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture. Osteoporosis is a serious public health problem that is responsible for approximately 3 million women with osteoporosis in France, with approximately 150,000 cases per year occurring in vertebral fractures, of which only one third would be diagnosed and 50,000 hip fractures (causing death in 20% of cases). The frequency of the disease increases with age, particularly among women: 10% among women aged 60 years and 20% among women aged 65 and 40% among women aged 75. At menopause, oestrogen deficiency causes alterations of the immune system, decreased bone formation, microarchitectural deterioration and a decrease in bone mass. Various factors may contribute to this decrease in bone density such as diet, lifestyle, or the genetic background.

According to prospective studies, an overexpression of 135% of hip fractures is expected at European level in 50 years. Therefore, it is interesting to develop new prevention approaches aimed at maintaining the healthy aging population. Nutritional researches can consider setting up a real prevention.

Studies suggest that specific milk protein fraction contain factors able to promote bone formation, inhibit bone resorption in vitro. In animal model, they showed that the specific fraction prevents bone loss in aged ovariectomised rats by reducing bone resorption. Furthermore, in human volunteers, a supplementation with the specific milk protein fraction maintains balanced bone remodelling and increase bone mineral density. For example, in healthy postmenopausal women, it has been reported that a mean rate of gain of lumbar BMD in the MPF group (1.21%) was significantly higher than in placebo group (-0.66%; p<0.05).

The objective of this study is to assess the efficacy of daily consumption of the milk proteins fraction on bone mineral density improvement in healthy postmenopausal women.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Caucasian Female
  • Natural or surgical menopause between 1 and 5 years
  • Aged between 50 to 65 years
  • BMI between 19 and 30 kg/m²

排除标准

  • Medications: oral steroidal anti-inflammatory, anti-osteoporotic treatment, hormone replacement therapy
  • Low bone mineral density (T-score<-3
  • Diseases affecting bone metabolism(Paget's disease, Cushing's disease, thyroid disease...)
  • Intolerance or allergy to milk proteins and allergy to soy or soy lecithin
  • Heavy smoking
  • Excessive alcohol drinking
  • Intensive sports practice according to the investigator

结局指标

主要结局

lumbar spine bone mineral density

时间窗: 24 months

次要结局

  • lumbar spine bone mineral density(12 months)
  • bone remodelling biomarkers(6 and 12 months)
  • femoral bone mineral density(12 and 24 months)

研究者

发起方
Soredab
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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