OsteoporosisPhase 1NCT01293045
Biological Bone Markers and Hydrolyzed Collagen Supplement in Menopausal Healthy Women
A Phase 1 study testing hydrolyzed collagen and wheat protein in people with Osteoporosis, run by Nealth Sarl at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- hydrolyzed collagen and wheat protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jan 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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.
- 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.
Who cannot join
- Bone density < 2.5 SD (standard deviation)
- Endocrine disease
- No history of fragility fracture bone
- Dietary disorder (anorexia, bulimia)
- Hormone replacement therapy
Trial locations and contacts
1 site in 1 country.
France1 site
CRNH - Centre de Recherche sur Volontaires - Hôpital AVICENNE
Bobigny, Seine-saint-denis, 93009
About this study
Official title: Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal 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.
- Conditions
- Osteoporosis
- Being tested
- hydrolyzed collagen, wheat protein
- Keywords
- Osteoporosis, Postmenopausal women, Functional food, Hydrolysed collagen, Bone metabolism, Bone marker of resorption, Bone marker of formation
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrolyzed collagenDietary supplement
10g/day at breakfast during 90 days
wheat proteinDietary supplement
10g/day at breakfast during 90 days
| Study group | Role | What they receive |
|---|---|---|
| HC Group | Experimental | Group of volunteers fed with Hydrolyzed Collagen Receives: Dietary Supplement: hydrolyzed collagen |
| CT Group | Active comparator | Group of volunteers fed with wheat proteins Receives: Dietary Supplement: wheat protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum C-terminal telopeptide of type 1 collagen (CTX)
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 45 days
Measured: Day 45
Secondary outcomes (9)
Urinary telopeptide N-terminal of type 1 collagen (NTX)
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 45 days
Measured: Day 45
Serum osteocalcin
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 45 days
Measured: Day 45
Serum bone alkaline phosphatase
MARKERS OF BONE FORMATION: change from Baseline (Day 0) in serum bone alkaline phosphatase at 45 days
Measured: Day 45
Serum amino-terminal pro-peptide of type 1 procollagen (P1NP)
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum P1NP at 45 days
Measured: Day 45
Urinary telopeptide N-terminal of type 1 collagen (NTX)
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in urinary NTX at 90 days
Measured: Day 90
Serum osteocalcin
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum osteocalcin at 90 days
Measured: Day 90
Serum bone alkaline phosphatase
MARKERS OF BONE FORMATION: change from Baseline (Day 0) in serum bone alkaline phosphatase at 90 days
Measured: Day 90
Serum amino-terminal pro-peptide of type 1 procollagen (P1NP)
MARKERS OF BONE FORMATION : change from Baseline (Day 0) in serum P1NP at 90 days
Measured: Day 90
Serum C-terminal telopeptide of type 1 collagen (CTX)
MARKERS OF BONE RESORPTION : change from Baseline (Day 0) in serum CTX at 90 days
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nealth Sarl
- Sponsor type
- Research network
- Collaborators
- ROUSSELOT SAS
- Responsible party
- Sponsor
- Investigators
- Robert BENAMOUZIG, MD, PhD, Principal investigator, Centre de Recherche en Nutrition Humaine d'Ile-de-France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293045
- Sponsor's protocol ID
- ROU_COLHYD09
- Other IDs
- 2009-A01217-50
- Status last verified
- Feb 2011
- First submitted
- 8 Feb 2011
- Last updated
- 9 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 16308135Takeuchi 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.
PubMed 8632016Wu 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.
PubMed 15490264Guillerminet 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.
PubMed 19895915
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Change in Biological Markers of Bone Metabolism Following Consumption of Hydrolyzed Collagen for 3 Months in Healthy, Non-osteoporotic, Menopausal Women.
- ClinicalTrials.gov ID
- NCT01293045
- Acronym / sponsor ID
- ROU_COLHYD09
- Conditions
- Osteoporosis
- Keywords
- Osteoporosis, Postmenopausal women, Functional food, Hydrolysed collagen, Bone metabolism, Bone marker of resorption, Bone marker of formation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nealth SarlResearch network
- Collaborators
- ROUSSELOT SAS
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 10 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HC Group | Experimental | Dietary Supplement: hydrolyzed collagenGroup of volunteers fed with Hydrolyzed Collagen |
| CT Group | Active comparator | Dietary Supplement: wheat proteinGroup of volunteers fed with wheat proteins |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- Bone density < 2.5 SD (standard deviation)
- Endocrine disease
- No history of fragility fracture bone
- Dietary disorder (anorexia, bulimia)
- Hormone replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrolyzed collagen10g/day at breakfast during 90 days | Dietary supplement | HC Group |
| wheat protein10g/day at breakfast during 90 days | Dietary supplement | CT Group |
Primary outcome
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
9 secondary outcomes
Urinary telopeptide N-terminal of type 1 collagen (NTX)
Time frame: Day 45
Serum osteocalcin
Time frame: Day 45
Serum bone alkaline phosphatase
Time frame: Day 45
Serum amino-terminal pro-peptide of type 1 procollagen (P1NP)
Time frame: Day 45
Urinary telopeptide N-terminal of type 1 collagen (NTX)
Time frame: Day 90
Serum osteocalcin
Time frame: Day 90
Serum bone alkaline phosphatase
Time frame: Day 90
Serum amino-terminal pro-peptide of type 1 procollagen (P1NP)
Time frame: Day 90
Serum C-terminal telopeptide of type 1 collagen (CTX)
Time frame: Day 90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2014.
- Background: PubMed 16308135Nomura 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.
- Background: PubMed 8632016Takeuchi 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.
- Background: PubMed 15490264Wu 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.
- Background: PubMed 19895915Guillerminet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert BENAMOUZIG, MD, PhD principal investigator
Centre de Recherche en Nutrition Humaine d'Ile-de-France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hydrolyzed collagen and wheat protein in people with Osteoporosis, run by Nealth Sarl at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum C-terminal telopeptide of type 1 collagen (CTX) (time frame: Day 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01293045, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2014.