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

December 16, 2024 updated by: Rousselot BVBA
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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Esslingen, Germany, 73728
        • BioTeSys GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: pre dose and up to 6 hours post dose
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.
Time Frame: pre dose and up to 6 hours post dose
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.
Time Frame: pre dose and up to 6 hours post dose
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
Time Frame: pre dose and up to 6 hours post dose
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
Time Frame: pre dose and up to 6 hours post dose
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
Time Frame: pre dose and up to 6 hours post dose
Pharmakokinetic variables
pre dose and up to 6 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rousselot BVBA

Collaborators

BioTeSys GmbH

Investigators

  • Study Director: Nicoletta Virgilio, PhD, RousselotBVBA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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