Trial | NCT01293045  Report issue

Title

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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    collagen wheat ...

  • Study Participants

    44
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 Started
Jun 30
2010
Primary Completion
Jan 31
2011
Study Completion
Jan 31
2011
Last Update
Apr 09
2014
Estimate

Dietary Supplement hydrolyzed collagen

10g/day at breakfast during 90 days

Dietary Supplement wheat protein

10g/day at breakfast during 90 days

HC Group Experimental

Group of volunteers fed with Hydrolyzed Collagen

CT Group Active Comparator

Group of volunteers fed with wheat proteins

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.
No Results Posted