Clinical trial NCT01293045: Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Keywords: Osteoporosis
Postmenopausal women
Functional food
Hydrolysed collagen
Bone metabolism
Bone marker of resorption
Bone marker of formation
Lead sponsor: Nealth Sarl
Sponsor class: NETWORK
Collaborators: name: ROUSSELOT SAS
First posted: 2011-02-10
Enrollment: 44
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility 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.

Primary outcomes:
measure: Serum C-terminal telopeptide of type 1 collagen (CTX)
timeFrame: Day 45
Secondary outcomes:
measure: Urinary telopeptide N-terminal of type 1 collagen (NTX)
timeFrame: Day 45
measure: Serum osteocalcin
timeFrame: Day 45
measure: Serum bone alkaline phosphatase
timeFrame: Day 45
measure: Serum amino-terminal pro-peptide of type 1 procollagen (P1NP)
timeFrame: Day 45
measure: Urinary telopeptide N-terminal of type 1 collagen (NTX)
timeFrame: Day 90
measure: Serum osteocalcin
timeFrame: Day 90
measure: Serum bone alkaline phosphatase
timeFrame: Day 90
measure: Serum amino-terminal pro-peptide of type 1 procollagen (P1NP)
timeFrame: Day 90
measure: Serum C-terminal telopeptide of type 1 collagen (CTX)
timeFrame: Day 90
Other outcomes:
Locations:
city: Bobigny
country: France
facility: CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE
state: Seine-saint-denis
Study officials:
affiliation: Centre de Recherche en Nutrition Humaine d'Ile-de-France
name: Robert BENAMOUZIG, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.