Clinical trial NCT05252962: Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects
Official title: Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Rousselot BVBA
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2022-02-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides.
timeFrame: pre dose and up to 6 hours post dose
measure: Peak plasma concentration after administration (Cmax) for hydroxyproline after single dose of the different collagen peptides.
timeFrame: pre dose and up to 6 hours post dose
measure: Time to reach the maximum concentration of hydroxyproline (Tmax) for hydroxyproline after single dose of the different collagen peptides.
timeFrame: pre dose and up to 6 hours post dose
Secondary outcomes:
measure: Area Under the Curve (AUC(0-6h)) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
timeFrame: pre dose and up to 6 hours post dose
measure: Peak plasma concentration after administration (Cmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
timeFrame: pre dose and up to 6 hours post dose
measure: Time to reach the maximum concentration (Tmax) of other characteristic amino acids, total amino acids, as well as the selected di- and tripeptides
timeFrame: pre dose and up to 6 hours post dose
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: RousselotBVBA
name: Nicoletta Virgilio, PhD
role: STUDY_DIRECTOR
References: