Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women - Full Text View

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 Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

U.S. FDA Resources

Further study details as provided by Nealth Sarl:

Primary Outcome Measures:

Serum C-terminal telopeptide of type 1 collagen (CTX) [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 45 days
Serum osteocalcin [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 45 days
Serum bone alkaline phosphatase [ Time Frame: Day 45 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 90 days
Serum osteocalcin [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 90 days
Serum bone alkaline phosphatase [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

CRNH web site This link exits the ClinicalTrials.gov site

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.


Responsible Party:	Nealth Sarl
ClinicalTrials.gov Identifier:	NCT01293045 History of Changes
Other Study ID Numbers:	ROU_COLHYD09, 2009-A01217-50
Study First Received:	February 8, 2011
Last Updated:	April 8, 2014
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nealth Sarl:


Osteoporosis Postmenopausal women Functional food Hydrolysed collagen	Bone metabolism Bone marker of resorption Bone marker of formation

ClinicalTrials.gov processed this record on March 03, 2015