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Completed

NCT Number: NCT01293045

Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy 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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE

Bobigny, Seine-saint-denis, 93009, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydrolyzed collagen

Dietary Supplement

10g/day at breakfast during 90 days

wheat protein

Dietary Supplement

10g/day at breakfast during 90 days

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Serum osteocalcin

    Time frame: Day 45

    MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 45 days

  3. 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

  4. 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

  5. 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

  6. Serum osteocalcin

    Time frame: Day 90

    MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 90 days

  7. 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

  8. 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

  9. 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

Sponsors and collaborators

Lead sponsor

Nealth Sarl

Network

Collaborators

  • ROUSSELOT SAS

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2011
Registry last updated
Apr 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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