Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478724
• Other study ID #: SORBONE
• Status: Completed
• Phase: Phase 1
• First received: November 21, 2011
• Last updated: May 22, 2015
• Start date: November 2011
• Est. completion date: May 2015

Study information

• Verified date: May 2015
• Source: Soredab
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• Milk proteins fraction
capsules, one per day, 24 months

Locations

Country	Name	City	State
France	Cochin hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Soredab

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lumbar spine bone mineral density		24 months	No
Secondary	femoral bone mineral density		12 and 24 months	No
Secondary	lumbar spine bone mineral density		12 months	No
Secondary	bone remodelling biomarkers		6 and 12 months	No