Healthy
Conditions
Brief 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.
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
Interventions
DIETARY_SUPPLEMENTCollagen Peptides
Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.
Sponsors
BioTeSys GmbH
Rousselot BVBA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double-blind
Intervention model description
The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
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.) * 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides. | 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. | 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. | pre dose and up to 6 hours post dose | Pharmakokinetic variable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve (AUC(0-6h)) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides | pre dose and up to 6 hours post dose | Pharmakokinetic variables |
| Peak plasma concentration after administration (Cmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides | pre dose and up to 6 hours post dose | Pharmakokinetic variables |
| Time to reach the maximum concentration (Tmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides | pre dose and up to 6 hours post dose | Pharmakokinetic variables |
Countries
Germany
Outcome results
None listed