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Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women
This study has been completed.
Sponsor:
Nealth Sarl
Collaborator:
ROUSSELOT SAS
Information provided by (Responsible Party):
Nealth Sarl
ClinicalTrials.gov Identifier:
NCT01293045
First received: February 8, 2011
Last updated: April 8, 2014
Last verified: February 2011
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Purpose
- 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 | Intervention | Phase |
|---|---|---|
| Osteoporosis | Dietary Supplement: hydrolyzed collagen Dietary Supplement: wheat protein | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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. |
Further study details as provided by Nealth Sarl:
Primary Outcome Measures:
- Serum C-terminal telopeptide of type 1 collagen (CTX) [ Time Frame: 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) [ Time Frame: Day 45 ]MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 45 days
- Serum osteocalcin [ Time Frame: Day 45 ]MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 45 days
- Serum bone alkaline phosphatase [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Day 90 ]MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 90 days
- Serum osteocalcin [ Time Frame: Day 90 ]MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 90 days
- Serum bone alkaline phosphatase [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Day 90 ]MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 90 days
| Enrollment: | 44 |
| Study Start Date: | June 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 55 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01293045
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293045
Locations
| France | |
| CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE | |
| Bobigny, Seine-saint-denis, France, 93009 | |
Sponsors and Collaborators
Nealth Sarl
ROUSSELOT SAS
Investigators
| Principal Investigator: | Robert BENAMOUZIG, MD, PhD | Centre de Recherche en Nutrition Humaine d'Ile-de-France |
More Information
Additional Information:
Publications:
| Responsible Party: | Nealth Sarl |
| ClinicalTrials.gov Identifier: | NCT01293045 History of Changes |
| Other Study ID Numbers: |
ROU_COLHYD09 2009-A01217-50 ( Registry Identifier: AFSSAPS (France) ) |
| Study First Received: | February 8, 2011 |
| Last Updated: | April 8, 2014 |
Keywords provided by Nealth Sarl:
|
Osteoporosis Postmenopausal women Functional food Hydrolysed collagen |
Bone metabolism Bone marker of resorption Bone marker of formation |
Additional relevant MeSH terms:
|
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 23, 2017