Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoporosis

Intervention / Treatment
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* Dietary Supplement: hydrolyzed collagen
* Dietary Supplement: wheat protein


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum C-terminal telopeptide of type 1 collagen (CTX) | MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 45 days | Day 45 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoporosis, Postmenopausal women, Functional food, Hydrolysed collagen, Bone metabolism, Bone marker of resorption, Bone marker of formation