Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: hydrolyzed collagen; Dietary Supplement: wheat protein

• Registration Number: NCT01293045
• Lead Sponsor: Nealth Sarl

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 available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Study First Submitted: 2011-02-08
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-10
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HC Group	hydrolyzed collagen	Group of volunteers fed with Hydrolyzed Collagen
CT Group	wheat protein	Group of volunteers fed with wheat proteins

Primary Outcome Measures

Name	Time	Method
Serum C-terminal telopeptide of type 1 collagen (CTX)	Day 45	MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 45 days

Secondary Outcome Measures

Name	Time	Method
Urinary telopeptide N-terminal of type 1 collagen (NTX)	Day 90	MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 90 days
Serum osteocalcin	Day 90	MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 90 days
Serum bone alkaline phosphatase	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)	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)	Day 90	MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 90 days

Trial Locations

Locations (1)

CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE; 🇫🇷 Bobigny, Seine-saint-denis, France