Collagen ProteinNCT03749239
Effects of Collagen Protein on the Amino Acid Profile of the Blood
A study testing Collagen protein in people with Collagen Protein, run by University of Aarhus at 1 site in Denmark.
Trial summary
This project aims to investigate the absorption of enzymatically hydrolysed and non-enzymatically hydrolysed collagen on the Amino acid profile of the blood Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Collagen Protein
- What is being tested?
- Collagen protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Nov 2018to 1 Mar 2019
- Phase
- Interventional
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
Who cannot join
- Medicine influencing protein turnover
- Diabetes
- Smoking
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University, Department for Public Health, Section for Sport Science
Aarhus, 8000
About this study
Official title: Effect of Intake of Enzymatically Hydrolyzed and Non-enzymatically Hydrolyzed Collagen Protein on the Amino Acid Profile of the Blood
This project aims to investigate the absorption of enzymatically hydrolysed and non-enzymatically hydrolysed collagen on the Amino acid profile of the blood
- Conditions
- Collagen Protein
- Being tested
- Collagen protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen proteinDietary supplement
Collagen protein
| Study group | Role | What they receive |
|---|---|---|
| Effects of collagen protein. | Experimental | Non-hydrolized collagen protein Receives: Dietary Supplement: Collagen protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid profile of the blood
AA concentrations in blood samples is determined using 1H NMR spectroscopy
Measured: Blood samples is collected at pre, 0 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min and 240 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start8 Nov 2018
- Primary completion15 Dec 2018
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Collagen ProteinStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749239
- Sponsor's protocol ID
- Collagen_2018
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intake of Enzymatically Hydrolyzed and Non-enzymatically Hydrolyzed Collagen Protein on the Amino Acid Profile of the Blood
- ClinicalTrials.gov ID
- NCT03749239
- Acronym / sponsor ID
- Collagen_2018
- Conditions
- Collagen Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- 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.
This project aims to investigate the absorption of enzymatically hydrolysed and non-enzymatically hydrolysed collagen on the Amino acid profile of the blood
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Effects of collagen protein. | Experimental | Dietary Supplement: Collagen proteinNon-hydrolized collagen protein |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy
Key exclusion criteria (3 listed)
- Medicine influencing protein turnover
- Diabetes
- Smoking
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 |
|---|---|---|
| Collagen proteinCollagen protein | Dietary supplement | Effects of collagen protein. |
Primary outcome
Amino acid profile of the blood
Time frame: Blood samples is collected at pre, 0 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min and 240 min.
AA concentrations in blood samples is determined using 1H NMR spectroscopy
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 May 2019.
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Preventing Muscle Loss After Bariatric Surgery: Protein-Collagen Supplementation and Resistance Exercise
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Active, not recruitingPhase 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen protein in people with Collagen Protein, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 3 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 May 2019. 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 Denmark. 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.
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?
Amino acid profile of the blood (time frame: Blood samples is collected at pre, 0 min, 20 min, 40 min, 60 min, 90 min, 120 min, 180 min and 240 min.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2019.