Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

Osteoporosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293045
• Other study ID #: ROU_COLHYD09
• Secondary ID: 2009-A01217-50
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2011
• Last updated: April 8, 2014
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: February 2011
• Source: Nealth Sarl
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Dietary Supplement:
• hydrolyzed collagen
10g/day at breakfast during 90 days
• wheat protein
10g/day at breakfast during 90 days

Locations

Country	Name	City	State
France	CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE	Bobigny	Seine-saint-denis

Sponsors (2)

Lead Sponsor	Collaborator
Nealth Sarl	ROUSSELOT SAS

Country where clinical trial is conducted

France, 

References & Publications (4)

Guillerminet F, Beaupied H, Fabien-Soulé V, Tomé 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Serum osteocalcin	MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 45 days	Day 45	No
Secondary	Serum bone alkaline phosphatase	MARKERS OF BONE FORMATION: change from Baseline (Day 0) in serum bone alkaline phosphatase at 45 days	Day 45	No
Secondary	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	No
Secondary	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	No
Secondary	Serum osteocalcin	MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 90 days	Day 90	No
Secondary	Serum bone alkaline phosphatase	MARKERS OF BONE FORMATION: change from Baseline (Day 0) in serum bone alkaline phosphatase at 90 days	Day 90	No
Secondary	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	No
Secondary	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	No

External Links

•   CRNH web site