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Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention

Primary Purpose

Osteoporosis

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Milk proteins fraction
Sponsored by
Soredab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cochin hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Milk protein fraction dose 1

Milk protein fraction dose 2

Arm Description

Animal proteins

Outcomes

Primary Outcome Measures

lumbar spine bone mineral density

Secondary Outcome Measures

femoral bone mineral density
lumbar spine bone mineral density
bone remodelling biomarkers

Full Information

First Posted
November 21, 2011
Last Updated
May 22, 2015
Sponsor
Soredab
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1. Study Identification

Unique Protocol Identification Number
NCT01478724
Brief Title
Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention
Official Title
Effects of Proteins Fraction Derived From Milk on Bone Mineral Density and Bone Metabolism in Healthy Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soredab

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
291 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Animal proteins
Arm Title
Milk protein fraction dose 1
Arm Type
Experimental
Arm Title
Milk protein fraction dose 2
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk proteins fraction
Intervention Description
capsules, one per day, 24 months
Primary Outcome Measure Information:
Title
lumbar spine bone mineral density
Time Frame
24 months
Secondary Outcome Measure Information:
Title
femoral bone mineral density
Time Frame
12 and 24 months
Title
lumbar spine bone mineral density
Time Frame
12 months
Title
bone remodelling biomarkers
Time Frame
6 and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Roux, PUPH
Organizational Affiliation
Cochin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin hospital
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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Effects of Proteins Fraction Derived From Milk on Osteoporosis Prevention

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