Osteoporosis
Conditions
Keywords
Osteoporosis, Postmenopausal women, Functional food, Hydrolysed collagen, Bone metabolism, Bone marker of resorption, Bone marker of formation
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.
Interventions
DIETARY_SUPPLEMENThydrolyzed collagen
10g/day at breakfast during 90 days
DIETARY_SUPPLEMENTwheat protein
10g/day at breakfast during 90 days
Sponsors
ROUSSELOT SAS
Nealth Sarl
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
France
Outcome results
None listed