Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Dietary supplement: Milk proteins fraction

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Animal proteins	Dietary supplement: Milk proteins fraction; capsules, one per day, 24 months
Experimental: Milk protein fraction dose 1	Dietary supplement: Milk proteins fraction; capsules, one per day, 24 months
Experimental: Milk protein fraction dose 2	Dietary supplement: Milk proteins fraction; capsules, one per day, 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
lumbar spine bone mineral density	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
femoral bone mineral density	12 and 24 months
lumbar spine bone mineral density	12 months
bone remodelling biomarkers	6 and 12 months

Collaborators and Investigators

• Sponsor: Soredab
• Investigators: Principal Investigator: Christian Roux, PUPH, Cochin Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: November 21, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: SORBONE