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OpenTrials
Completed

NCT Number: NCT01478724

Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention

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.

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Key information

Age range

50 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Cochin hospital

Paris, 75014, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Milk proteins fraction

Dietary Supplement

capsules, one per day, 24 months

Primary outcomes

  1. lumbar spine bone mineral density

    Time frame: 24 months

Secondary outcomes

  1. femoral bone mineral density

    Time frame: 12 and 24 months

  2. lumbar spine bone mineral density

    Time frame: 12 months

  3. bone remodelling biomarkers

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Soredab

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 23, 2011
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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