Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal Women.

• 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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Dietary supplement: hydrolyzed collagen; Dietary supplement: wheat protein

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Serum osteocalcin	MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 45 days	Day 45
Serum bone alkaline phosphatase	MARKERS OF BONE FORMATION: change from Baseline (Day 0) in serum bone alkaline phosphatase at 45 days	Day 45
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
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
Serum osteocalcin	MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 90 days	Day 90
Serum bone alkaline phosphatase	MARKERS OF BONE FORMATION: change from Baseline (Day 0) in serum bone alkaline phosphatase at 90 days	Day 90
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
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

Collaborators and Investigators

• Sponsor: Nealth Sarl
• Collaborators: ROUSSELOT SAS
• Investigators: Principal Investigator: Robert BENAMOUZIG, MD, PhD, Centre de Recherche en Nutrition Humaine d'Ile-de-France

Publications and helpful links

General 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. 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 8, 2011
• First Submitted That Met QC Criteria: February 8, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Osteoporosis; Bone metabolism; Postmenopausal women; Functional food; Hydrolysed collagen; Bone marker of resorption; Bone marker of formation
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis
• Other Study ID Numbers: ROU_COLHYD09; 2009-A01217-50 (Registry Identifier: AFSSAPS (France))