HealthyNCT05252962
Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects
A study testing Collagen Peptides in people with Healthy, run by Rousselot BVBA at 1 site in Germany.
Trial summary
The aim of this study is to evaluate the relative bioavailability of Peptan® Type I collagen peptides from different marine origin (different fish sources, production process and molecular weight) in healthy human subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Collagen Peptides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- 26 Nov 2021to 17 May 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Age: 18 - 50 years
- Healthy men and women
- BMI: 19 - 28 kg/m2
- Non-smoker
Who cannot join
- Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
- A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure
- Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
- For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- Blood donation within 1 month prior to study start or during study
- "Extreme dietary regimes": vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal for men
Show all 9Show fewer
- Intake of anticoagulants like Heparin, Marcumar etc.
- Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during study
- History of hypersensitivity to fish
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate the relative bioavailability of Peptan® Type I collagen peptides from different marine origin (different fish sources, production process and molecular weight) in healthy human subjects.
Read the detailed description
The aim of this study is to evaluate the relative bioavailability of different Peptan® Type I collagen peptides in healthy human subjects. The pharmacokinetic parameters AUC0-6h, Cmax and Tmax will be determined from the concentration-time curves of characteristic collagen markers (e.g. hydroxyproline, proline, glycine, di- and tripeptides together with further amino acids) after oral single dose administration.
The following objectives will be evaluated by comparison of pharmacokinetic parameters between the products:
- The impact of different production processes
- The impact of size of collagen peptides
- The impact of different fish sources
- Conditions
- Healthy
- Being tested
- Collagen Peptides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen PeptidesDietary supplement
Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.
| Study group | Role | What they receive |
|---|---|---|
| marine collagen peptide production process I | Experimental | standardized to 10 g provided as single dose. Orally applied in water. Receives: Dietary Supplement: Collagen Peptides |
| marine collagen peptide production process II | Experimental | standardized to 10 g provided as single dose. Orally applied in water. Receives: Dietary Supplement: Collagen Peptides |
| marine collagen peptide fish source I | Experimental | standardized to 10 g provided as single dose. Orally applied in water. Receives: Dietary Supplement: Collagen Peptides |
| marine collagen peptide fish source II | Experimental | standardized to 10 g provided as single dose. Orally applied in water. Receives: Dietary Supplement: Collagen Peptides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides.
Pharmakokinetic variable
Measured: pre dose and up to 6 hours post dose
Peak plasma concentration after administration (Cmax) for hydroxyproline after single dose of the different collagen peptides.
Pharmakokinetic variable
Measured: pre dose and up to 6 hours post dose
Time to reach the maximum concentration of hydroxyproline (Tmax) for hydroxyproline after single dose of the different collagen peptides.
Pharmakokinetic variable
Measured: pre dose and up to 6 hours post dose
Secondary outcomes (3)
Area Under the Curve (AUC(0-6h)) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
Pharmakokinetic variables
Measured: pre dose and up to 6 hours post dose
Peak plasma concentration after administration (Cmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
Pharmakokinetic variables
Measured: pre dose and up to 6 hours post dose
Time to reach the maximum concentration (Tmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
Pharmakokinetic variables
Measured: pre dose and up to 6 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start26 Nov 2021
- Primary completion17 Feb 2022
- Study completion17 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rousselot BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
- Investigators
- Nicoletta Virgilio, PhD, Study director, RousselotBVBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252962
- Sponsor's protocol ID
- BTS1786/21
- Status last verified
- Mar 2022
- First submitted
- 1 Feb 2022
- Last updated
- 17 Dec 2024
- 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 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05252962
- Acronym / sponsor ID
- BTS1786/21
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Rousselot BVBAIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 23 Feb 2022 (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.
The aim of this study is to evaluate the relative bioavailability of Peptan® Type I collagen peptides from different marine origin (different fish sources, production process and molecular weight) in healthy human subjects.
Detailed description
The aim of this study is to evaluate the relative bioavailability of different Peptan® Type I collagen peptides in healthy human subjects. The pharmacokinetic parameters AUC0-6h, Cmax and Tmax will be determined from the concentration-time curves of characteristic collagen markers (e.g. hydroxyproline, proline, glycine, di- and tripeptides together with further amino acids) after oral single dose administration.
The following objectives will be evaluated by comparison of pharmacokinetic parameters between the products:
- The impact of different production processes
- The impact of size of collagen peptides
- The impact of different fish sources
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
| Arm | Type | Receives |
|---|---|---|
| marine collagen peptide production process I | Experimental | Dietary Supplement: Collagen Peptidesstandardized to 10 g provided as single dose. Orally applied in water. |
| marine collagen peptide production process II | Experimental | Dietary Supplement: Collagen Peptidesstandardized to 10 g provided as single dose. Orally applied in water. |
| marine collagen peptide fish source I | Experimental | Dietary Supplement: Collagen Peptidesstandardized to 10 g provided as single dose. Orally applied in water. |
| marine collagen peptide fish source II | Experimental | Dietary Supplement: Collagen Peptidesstandardized to 10 g provided as single dose. Orally applied in water. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Age: 18 - 50 years
- Healthy men and women
- BMI: 19 - 28 kg/m2
- Non-smoker
Key exclusion criteria (9 listed)
- Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
- A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure
- Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
- For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
- Blood donation within 1 month prior to study start or during study
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 PeptidesCollagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake. | Dietary supplement | marine collagen peptide fish source I, marine collagen peptide fish source II, marine collagen peptide production process I, marine collagen peptide production process II |
Primary outcome
Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides.
Time frame: pre dose and up to 6 hours post dose
Pharmakokinetic variable
Peak plasma concentration after administration (Cmax) for hydroxyproline after single dose of the different collagen peptides.
Time frame: pre dose and up to 6 hours post dose
Pharmakokinetic variable
Time to reach the maximum concentration of hydroxyproline (Tmax) for hydroxyproline after single dose of the different collagen peptides.
Time frame: pre dose and up to 6 hours post dose
Pharmakokinetic variable
3 secondary outcomes
Area Under the Curve (AUC(0-6h)) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
Time frame: pre dose and up to 6 hours post dose
Peak plasma concentration after administration (Cmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
Time frame: pre dose and up to 6 hours post dose
Time to reach the maximum concentration (Tmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
Time frame: pre dose and up to 6 hours post dose
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 17 Dec 2024.
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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.
Nicoletta Virgilio, PhD study director
RousselotBVBA
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 Peptides in people with Healthy, run by Rousselot BVBA at 1 site in Germany.
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 5 inclusion and 9 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 17 Dec 2024. 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 Germany. 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?
Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides. (time frame: pre dose and up to 6 hours post dose). The study lists 3 primary outcomes in all. 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 17 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.