NCT01293045

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 8, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
Last Updated

April 9, 2014

Status Verified

February 1, 2011

Enrollment Period

7 months

First QC Date

February 8, 2011

Last Update Submit

April 8, 2014

Conditions

Osteoporosis

Keywords

OsteoporosisPostmenopausal womenFunctional foodHydrolysed collagenBone metabolismBone marker of resorptionBone marker of formation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Urinary telopeptide N-terminal of type 1 collagen (NTX)

    Day 45

  • Serum osteocalcin

    Day 45

  • Serum bone alkaline phosphatase

    Day 45

  • Serum amino-terminal pro-peptide of type 1 procollagen (P1NP)

    Day 45

  • Urinary telopeptide N-terminal of type 1 collagen (NTX)

    Day 90

  • +4 more secondary outcomes

Study Arms (2)

HC Group

EXPERIMENTAL

Group of volunteers fed with Hydrolyzed Collagen

Dietary Supplement: hydrolyzed collagen

CT Group

ACTIVE COMPARATOR

Group of volunteers fed with wheat proteins

Dietary Supplement: wheat protein

Interventions

hydrolyzed collagenDIETARY_SUPPLEMENT

10g/day at breakfast during 90 days

HC Group
wheat proteinDIETARY_SUPPLEMENT

10g/day at breakfast during 90 days

CT Group

Eligibility Criteria

Age55 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Bone density \< 2.5 SD (standard deviation)
  • Endocrine disease
  • No history of fragility fracture bone
  • Dietary disorder (anorexia, bulimia)
  • Hormone replacement therapy
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE

Bobigny, Seine-saint-denis, 93009, France

Location

Related Publications (4)

  • 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.

    PMID: 16308135BACKGROUND

  • 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.

    PMID: 8632016BACKGROUND

  • 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.

    PMID: 15490264BACKGROUND

  • 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.

    PMID: 19895915BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Robert BENAMOUZIG, MD, PhD

    Centre de Recherche en Nutrition Humaine d'Ile-de-France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2011

First Posted

February 10, 2011

Study Start

June 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

April 9, 2014

Record last verified: 2011-02

Locations

FR(1)