Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Collagen Peptides

• Registration Number: NCT05252962
• Lead Sponsor: Rousselot BVBA

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

Study Timeline

• Study Start: 2021-11-26
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-14
• Primary Completion: 2022-02-17
• Study First Posted: 2022-02-23
• Status Verified: 2022-03
• Study Completion: 2023-05-17
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
marine collagen peptide fish source II	Collagen Peptides	standardized to 10 g provided as single dose. Orally applied in water.
marine collagen peptide production process I	Collagen Peptides	standardized to 10 g provided as single dose. Orally applied in water.
marine collagen peptide fish source I	Collagen Peptides	standardized to 10 g provided as single dose. Orally applied in water.
marine collagen peptide production process II	Collagen Peptides	standardized to 10 g provided as single dose. Orally applied in water.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

BioTeSys GmbH; 🇩🇪 Esslingen, Germany