Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal Women.
| Registry | NCT01293045 |
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| Status | Completed |
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| Phase | Phase 1 |
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| Study type | Interventional; randomized, parallel, masking: quadruple |
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| Enrollment | 44 (Actual) |
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| Sponsor | Nealth Sarl (Network); collaborators: ROUSSELOT SAS |
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| Conditions | Osteoporosis |
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| Interventions | hydrolyzed collagen, wheat protein (Dietary supplement) |
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| Dates | start 2010-06-01, primary completion 2011-01-01, completion 2011-01-01, first posted 2011-02-10, last updated 2014-04-09 |
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| Locations | 1 site in France |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| HC Group | Experimental | Dietary Supplement: hydrolyzed collagen | Group of volunteers fed with Hydrolyzed Collagen |
| CT Group | Active comparator | Dietary Supplement: wheat protein | Group of volunteers fed with wheat proteins |
- hydrolyzed collagen (Dietary supplement): 10g/day at breakfast during 90 days
- wheat protein (Dietary supplement): 10g/day at breakfast during 90 days
+Outcome measures
Primary outcomes
- 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 outcomes
- Urinary telopeptide N-terminal of type 1 collagen (NTX) [Day 45]: MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 45 days
- Serum osteocalcin [Day 45]: MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 45 days
- Serum bone alkaline phosphatase [Day 45]: 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) [Day 45]: MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum P1NP at 45 days
- 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
+Eligibility
Sex: Female, ages: 55 Years to 65 Years, 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.
+Locations (1)
| Facility | City | Country | Status |
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| CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE | Bobigny, Seine-saint-denis | France | |
+Publications
- Nomura Y, Oohashi K, Watanabe M, Kasugai S. Increase in bone mineral density through oral administration of shark gelatin to ovariectomized rats. Nutrition. 2005 Nov-Dec;21(11-12):1120-6. doi: 10.1016/j.nut.2005.03.007. PMID 16308135
- Takeuchi Y, Nakayama K, Matsumoto T. Differentiation and cell surface expression of transforming growth factor-beta receptors are regulated by interaction with matrix collagen in murine osteoblastic cells. J Biol Chem. 1996 Feb 16;271(7):3938-44. doi: 10.1074/jbc.271.7.3938. PMID 8632016
- Wu J, Fujioka M, Sugimoto K, Mu G, Ishimi Y. Assessment of effectiveness of oral administration of collagen peptide on bone metabolism in growing and mature rats. J Bone Miner Metab. 2004;22(6):547-53. doi: 10.1007/s00774-004-0522-2. PMID 15490264
- Guillerminet F, Beaupied H, Fabien-Soule V, Tome D, Benhamou CL, Roux C, Blais A. Hydrolyzed collagen improves bone metabolism and biomechanical parameters in ovariectomized mice: an in vitro and in vivo study. Bone. 2010 Mar;46(3):827-34. doi: 10.1016/j.bone.2009.10.035. Epub 2009 Nov 4. PMID 19895915
+Investigators
- Robert BENAMOUZIG, MD, PhD, Principal investigator, Centre de Recherche en Nutrition Humaine d'Ile-de-France