Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

Sponsor

Nealth Sarl (Other)

Overall Status

Completed

CT.gov ID

NCT01293045

Collaborator

ROUSSELOT SAS (Other)

Enrollment

Location

Arms

Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Preliminary scientific studies, in both animals and humans suggest that oral consumption of hydrolyzed collagen acts on the bone remodeling process by stimulating the activity of osteoblasts responsible for bone formation while improving the bone mineral density and biomechanical resistance of long bones.
The objective of this clinical research is to measure changes in biomarkers of bone turnover in postmenopausal healthy women, not osteoporotic, in response to consumption of hydrolyzed collagen for three months.
For this, we propose to measure blood and urinary markers of formation and bone resorption before consumption, then 45 and 90 days after daily consumption of 10 g of hydrolyzed collagen.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Dietary Supplement: hydrolyzed collagen Dietary Supplement: wheat protein	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Official Title:

Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal Women.

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HC Group Group of volunteers fed with Hydrolyzed Collagen	Dietary Supplement: hydrolyzed collagen 10g/day at breakfast during 90 days
Active Comparator: CT Group Group of volunteers fed with wheat proteins	Dietary Supplement: wheat protein 10g/day at breakfast during 90 days

Arm

Intervention/Treatment

Experimental: HC Group

Group of volunteers fed with Hydrolyzed Collagen

Dietary Supplement: hydrolyzed collagen

10g/day at breakfast during 90 days

Active Comparator: CT Group

Group of volunteers fed with wheat proteins

Dietary Supplement: wheat protein

10g/day at breakfast during 90 days

Outcome Measures

Primary Outcome Measures

Serum C-terminal telopeptide of type 1 collagen (CTX) [Day 45]
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 45 days

Secondary Outcome Measures

Urinary telopeptide N-terminal of type 1 collagen (NTX) [Day 45]
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 45 days
Serum osteocalcin [Day 45]
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 45 days
Serum bone alkaline phosphatase [Day 45]
MARKERS OF BONE FORMATION: change from Baseline (Day 0) in serum bone alkaline phosphatase at 45 days
Serum amino-terminal pro-peptide of type 1 procollagen (P1NP) [Day 45]
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum P1NP at 45 days
Urinary telopeptide N-terminal of type 1 collagen (NTX) [Day 90]
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 90 days
Serum osteocalcin [Day 90]
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 90 days
Serum bone alkaline phosphatase [Day 90]
MARKERS OF BONE FORMATION: change from Baseline (Day 0) in serum bone alkaline phosphatase at 90 days
Serum amino-terminal pro-peptide of type 1 procollagen (P1NP) [Day 90]
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum P1NP at 90 days
Serum C-terminal telopeptide of type 1 collagen (CTX) [Day 90]
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 90 days

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy women
Aged between 55 and 65 years
Primary or secondary amenorrhea for at least 5 years
BMI ≥ 20 kg/m2 and < 27 kg/m2
DXA > 2.5 SD
No history of fragility fracture bone
Not under guardianship
Not on hormone replacement or any osteoporotic therapy
Covered by Social Security
Negative serology for hepatitis B/C and HIV
Written informed consent form signed.

Exclusion Criteria:

Bone density < 2.5 SD (standard deviation)
Endocrine disease
No history of fragility fracture bone
Dietary disorder (anorexia, bulimia)
Hormone replacement therapy
Inclusion in another clinical study
Subjects receiving over 4,500 Euros in the last 12 months (including the present study)
Subjects presenting risk of non-compliance in the opinion of the recruiting doctor.