Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women
NCT ID: NCT01293045
Last Updated: 2014-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2010-06-30
2011-01-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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HC Group
Group of volunteers fed with Hydrolyzed Collagen
hydrolyzed collagen
10g/day at breakfast during 90 days
CT Group
Group of volunteers fed with wheat proteins
wheat protein
10g/day at breakfast during 90 days
Interventions
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hydrolyzed collagen
10g/day at breakfast during 90 days
wheat protein
10g/day at breakfast during 90 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
65 Years
FEMALE
Yes
Sponsors
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ROUSSELOT SAS
UNKNOWN
Nealth Sarl
NETWORK
Responsible Party
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Principal Investigators
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Robert BENAMOUZIG, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre de Recherche en Nutrition Humaine d'Ile-de-France
Locations
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CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE
Bobigny, Seine-saint-denis, France
Countries
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References
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Nomura Y, Oohashi K, Watanabe M, Kasugai S. Increase in bone mineral density through oral administration of shark gelatin to ovariectomized rats. Nutrition. 2005 Nov-Dec;21(11-12):1120-6. doi: 10.1016/j.nut.2005.03.007.
Takeuchi Y, Nakayama K, Matsumoto T. Differentiation and cell surface expression of transforming growth factor-beta receptors are regulated by interaction with matrix collagen in murine osteoblastic cells. J Biol Chem. 1996 Feb 16;271(7):3938-44. doi: 10.1074/jbc.271.7.3938.
Wu J, Fujioka M, Sugimoto K, Mu G, Ishimi Y. Assessment of effectiveness of oral administration of collagen peptide on bone metabolism in growing and mature rats. J Bone Miner Metab. 2004;22(6):547-53. doi: 10.1007/s00774-004-0522-2.
Guillerminet F, Beaupied H, Fabien-Soule V, Tome D, Benhamou CL, Roux C, Blais A. Hydrolyzed collagen improves bone metabolism and biomechanical parameters in ovariectomized mice: an in vitro and in vivo study. Bone. 2010 Mar;46(3):827-34. doi: 10.1016/j.bone.2009.10.035. Epub 2009 Nov 4.
Other Identifiers
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2009-A01217-50
Identifier Type: REGISTRY
Identifier Source: secondary_id
ROU_COLHYD09
Identifier Type: -
Identifier Source: org_study_id
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