Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

Nealth Sarl

Status and phase: Completed; Phase 1

Conditions: Osteoporosis

Treatments: Dietary Supplement: wheat protein; Dietary Supplement: hydrolyzed collagen

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT01293045

2009-A01217-50 (Registry Identifier)

ROU_COLHYD09

Details and patient eligibility

About

• 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.

Enrollment: 44 patients

Sex: Female

Ages: 55 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

HC Group

Experimental group

Description:

Group of volunteers fed with Hydrolyzed Collagen

Treatment:

Dietary Supplement: hydrolyzed collagen

CT Group

Active Comparator group

Description:

Group of volunteers fed with wheat proteins

Treatment:

Dietary Supplement: wheat protein