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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Collagen Peptides

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: marine collagen peptide production process I; standardized to 10 g provided as single dose. Orally applied in water.	Dietary supplement: Collagen Peptides; Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.
Experimental: marine collagen peptide production process II; standardized to 10 g provided as single dose. Orally applied in water.	Dietary supplement: Collagen Peptides; Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.
Experimental: marine collagen peptide fish source I; standardized to 10 g provided as single dose. Orally applied in water.	Dietary supplement: Collagen Peptides; Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.
Experimental: marine collagen peptide fish source II; standardized to 10 g provided as single dose. Orally applied in water.	Dietary supplement: Collagen Peptides; Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides.	Pharmakokinetic variable	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	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	pre dose and up to 6 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	pre dose and up to 6 hours post dose

Collaborators and Investigators

• Sponsor: Rousselot BVBA
• Collaborators: BioTeSys GmbH
• Investigators: Study Director: Nicoletta Virgilio, PhD, RousselotBVBA

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2021
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): May 17, 2023

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2024
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: BTS1786/21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No