Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

This study has been completed.
Sponsor:
Collaborator:
ROUSSELOT SAS
Information provided by (Responsible Party):
Nealth Sarl
ClinicalTrials.gov Identifier:
NCT01293045
First received: February 8, 2011
Last updated: April 8, 2014
Last verified: February 2011
  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:


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:
Publications:
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

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 26, 2014