BioavailabilityNCT04097808
Impact of the Source and Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
A study testing collagen peptides in people with Bioavailability, run by Rousselot BVBA at 1 site in Germany.
Trial summary
The aim of this study is the comparison of the oral bioavailability of hydroxyproline, a key marker for collagen peptide intake, after ingestion of collagen peptides from different sources, sizes and together with different food matrices, either containing high or low levels of polyphenols. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- 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
- 6 participants
- Where
- 1 siteGermany
- Study dates
- 20 Sep 2019to 25 Oct 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- Sex: female and male (50 % of each gender)
- Age: 18-50 years
- BMI ≥19 and ≤28 kg/m²
- Nonsmoker
Main Exclusion Criteria:
- 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.)
- Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
- Application of corticoids (intravenously, orally or intraarticularly) and other immune-suppressing drug (within last 2 weeks)
- Blood donation within 1 month prior to study start or during study
- Regular intake of drugs or supplements possibly interfering with this study (Glucosamine, chondroitin sulfate, hyaluronic acid, omega-3, folic acid, curcumin/turmeric, Boswellia serrata, collagen, Vitamin D) within 2 weeks prior to study start or during study
- Intake of anticoagulants like Heparin, Marcumar etc.
- Coffee consumption >3 cups / day
- History of hypersensitivity to fish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the Source and Polyphenol-containing Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
The aim of this study is the comparison of the oral bioavailability of hydroxyproline, a key marker for collagen peptide intake, after ingestion of collagen peptides from different sources, sizes and together with different food matrices, either containing high or low levels of polyphenols.
Read the detailed description
The absorption (blood) of collagen peptides from bovine, fish and porcine source in different sizes and administered together with foods of different polyphenol content will be assessed. Pharmacokinetic parameters (AUC0-6h, Cmax and Tmax) after oral single dose administration will be determined to estimate the impact of different sources, different peptide sized any food matrix.
The following objectives will be evaluated exploratory by comparison of pharmacokinetic parameters from the concentration time curve of hydroxyproline, a key marker of collagen type I, between:
- different sources of collagen peptides (bovine, fish, porcine)
- different sizes of collagen peptides from cattle
- food matrices impact on uptake of bovine collagen peptides (dissolved in water vs. food matrix 1 vs. food matrix 2).
Additionally, concentration time curves of further amino acids will be assessed descriptively.
- Conditions
- Bioavailability
- Being tested
- collagen peptides
- Keywords
- bioavailability, collagen peptides, polyphenols
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 |
|---|---|---|
| collagen peptide bovine high molecular weight-Water | Experimental | source: bovine; standardized to 10 g provided as single dose. Orally applied in water. Receives: Dietary Supplement: collagen peptides |
| collagen peptide bovine low molecular weight-Water | Experimental | source: bovine; standardized to 10 g provided as single dose. Orally applied in water. Receives: Dietary Supplement: collagen peptides |
| collagen peptide bovine low molecular weight- food matrix 1 | Experimental | source: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 1 Receives: Dietary Supplement: collagen peptides |
| collagen peptide bovine low molecular weight- food matrix 2 | Experimental | source: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 2 Receives: Dietary Supplement: collagen peptides |
| collagen peptide fish low molecular weight-Water | Experimental | source: fish; standardized to 10 g provided as single dose. Orally applied in water. Receives: Dietary Supplement: collagen peptides |
| collagen peptide porcine low molecular weight-Water | Experimental | source: porcine; 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)
Pharmakokinetic variable
Measured: pre dose and up to 6 hours post dose
Secondary outcomes (1)
Concentration-time of essential and not essential amino acids
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 posted20 Sep 2019
- Study start20 Sep 2019
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioavailabilityStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rousselot BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
- Investigators
- Daniel Menzel, MD, Principal investigator, BioTeSys GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04097808
- Sponsor's protocol ID
- BTS1362/19
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Source and Polyphenol-containing Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04097808
- Acronym / sponsor ID
- BTS1362/19
- Conditions
- Bioavailability
- Keywords
- bioavailability, collagen peptides, polyphenols
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rousselot BVBAIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 20 Sep 2019 (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 the comparison of the oral bioavailability of hydroxyproline, a key marker for collagen peptide intake, after ingestion of collagen peptides from different sources, sizes and together with different food matrices, either containing high or low levels of polyphenols.
Detailed description
The absorption (blood) of collagen peptides from bovine, fish and porcine source in different sizes and administered together with foods of different polyphenol content will be assessed. Pharmacokinetic parameters (AUC0-6h, Cmax and Tmax) after oral single dose administration will be determined to estimate the impact of different sources, different peptide sized any food matrix.
The following objectives will be evaluated exploratory by comparison of pharmacokinetic parameters from the concentration time curve of hydroxyproline, a key marker of collagen type I, between:
- different sources of collagen peptides (bovine, fish, porcine)
- different sizes of collagen peptides from cattle
- food matrices impact on uptake of bovine collagen peptides (dissolved in water vs. food matrix 1 vs. food matrix 2).
Additionally, concentration time curves of further amino acids will be assessed descriptively.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
| Arm | Type | Receives |
|---|---|---|
| collagen peptide bovine high molecular weight-Water | Experimental | Dietary Supplement: collagen peptidessource: bovine; standardized to 10 g provided as single dose. Orally applied in water. |
| collagen peptide bovine low molecular weight-Water | Experimental | Dietary Supplement: collagen peptidessource: bovine; standardized to 10 g provided as single dose. Orally applied in water. |
| collagen peptide bovine low molecular weight- food matrix 1 | Experimental | Dietary Supplement: collagen peptidessource: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 1 |
| collagen peptide bovine low molecular weight- food matrix 2 | Experimental | Dietary Supplement: collagen peptidessource: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 2 |
| collagen peptide fish low molecular weight-Water | Experimental | Dietary Supplement: collagen peptidessource: fish; standardized to 10 g provided as single dose. Orally applied in water. |
| collagen peptide porcine low molecular weight-Water | Experimental | Dietary Supplement: collagen peptidessource: porcine; standardized 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
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 | collagen peptide bovine high molecular weight-Water, collagen peptide bovine low molecular weight- food matrix 1, collagen peptide bovine low molecular weight- food matrix 2, collagen peptide bovine low molecular weight-Water, collagen peptide fish low molecular weight-Water, collagen peptide porcine low molecular weight-Water |
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)
Time frame: pre dose and up to 6 hours post dose
Pharmakokinetic variable
1 secondary outcome
Concentration-time of essential and not essential amino acids
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 30 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Daniel Menzel, MD principal investigator
BioTeSys GmbH
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 Bioavailability, 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?
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 30 Apr 2020. 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 30 Apr 2020.