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Completed

NCT Number: NCT05252962

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen Peptides

Dietary Supplement

Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Rousselot BVBA

Industry

Collaborators

  • BioTeSys GmbH

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Feb 23, 2022
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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