Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

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ClinicalTrials.gov Identifier: NCT01293045

Recruitment Status : Completed

First Posted : February 10, 2011

Last Update Posted : April 9, 2014

Sponsor:

Collaborator:

ROUSSELOT SAS

Information provided by (Responsible Party):

Nealth Sarl

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoporosis	Dietary Supplement: hydrolyzed collagen Dietary Supplement: wheat protein	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	44 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (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.
Study Start Date :	June 2010
Actual Primary Completion Date :	January 2011
Actual Study Completion Date :	January 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

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

Eligibility Criteria

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Ages Eligible for Study:	55 Years to 65 Years (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01293045

Locations

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France
CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE
Bobigny, Seine-saint-denis, France, 93009

Sponsors and Collaborators

Nealth Sarl

ROUSSELOT SAS

Investigators

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Principal Investigator:	Robert BENAMOUZIG, MD, PhD	Centre de Recherche en Nutrition Humaine d'Ile-de-France

More Information

Publications:

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.

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.

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.

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.

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Responsible Party:	Nealth Sarl
ClinicalTrials.gov Identifier:	NCT01293045
Other Study ID Numbers:	ROU_COLHYD09 2009-A01217-50 ( Registry Identifier: AFSSAPS (France) )
First Posted:	February 10, 2011 Key Record Dates
Last Update Posted:	April 9, 2014
Last Verified:	February 2011

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:

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Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases

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