Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Soredab
ClinicalTrials.gov Identifier:
NCT01478724
First received: November 21, 2011
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Osteoporosis
Dietary Supplement: Milk proteins fraction
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effects of Proteins Fraction Derived From Milk on Bone Mineral Density and Bone Metabolism in Healthy Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Soredab:

Primary Outcome Measures:
  • lumbar spine bone mineral density [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • femoral bone mineral density [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • lumbar spine bone mineral density [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • bone remodelling biomarkers [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 291
Study Start Date: November 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478724

Locations
France
Cochin hospital
Paris, France, 75014
Sponsors and Collaborators
Soredab
Investigators
Principal Investigator: Christian Roux, PUPH Cochin Hospital
  More Information

No publications provided

Responsible Party: Soredab
ClinicalTrials.gov Identifier: NCT01478724     History of Changes
Other Study ID Numbers: SORBONE
Study First Received: November 21, 2011
Last Updated: May 26, 2014
Health Authority: France: Committee for the Protection of Personnes

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014