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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

Tracking Information
First Submitted Date  ICMJE February 8, 2011
First Posted Date  ICMJE February 10, 2011
Last Update Posted Date April 9, 2014
Study Start Date  ICMJE June 2010
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2011)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women
Official Title  ICMJE Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal Women.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE Osteoporosis
Intervention  ICMJE
  • Dietary Supplement: hydrolyzed collagen
    10g/day at breakfast during 90 days
  • Dietary Supplement: wheat protein
    10g/day at breakfast during 90 days
Study Arms  ICMJE
  • Experimental: HC Group
    Group of volunteers fed with Hydrolyzed Collagen
    Intervention: Dietary Supplement: hydrolyzed collagen
  • Active Comparator: CT Group
    Group of volunteers fed with wheat proteins
    Intervention: Dietary Supplement: wheat protein
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2011)
44
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 55 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01293045
Other Study ID Numbers  ICMJE ROU_COLHYD09
2009-A01217-50 ( Registry Identifier: AFSSAPS (France) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nealth Sarl
Study Sponsor  ICMJE Nealth Sarl
Collaborators  ICMJE ROUSSELOT SAS
Investigators  ICMJE
Principal Investigator: Robert BENAMOUZIG, MD, PhD Centre de Recherche en Nutrition Humaine d'Ile-de-France
PRS Account Nealth Sarl
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP