NCT05252962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2022

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2023

Completed
Last Updated

December 17, 2024

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

February 1, 2022

Last Update Submit

December 16, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (4)

marine collagen peptide production process I

EXPERIMENTAL

standardized to 10 g provided as single dose. Orally applied in water.

Dietary Supplement: Collagen Peptides

marine collagen peptide production process II

EXPERIMENTAL

standardized to 10 g provided as single dose. Orally applied in water.

Dietary Supplement: Collagen Peptides

marine collagen peptide fish source I

EXPERIMENTAL

standardized to 10 g provided as single dose. Orally applied in water.

Dietary Supplement: Collagen Peptides

marine collagen peptide fish source II

EXPERIMENTAL

standardized to 10 g provided as single dose. Orally applied in water.

Dietary Supplement: Collagen Peptides

Interventions

Collagen PeptidesDIETARY_SUPPLEMENT

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

marine collagen peptide fish source Imarine collagen peptide fish source IImarine collagen peptide production process Imarine collagen peptide production process II

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

Study Officials

  • Nicoletta Virgilio, PhD

    RousselotBVBA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blind
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 23, 2022

Study Start

November 26, 2021

Primary Completion

February 17, 2022

Study Completion

May 17, 2023

Last Updated

December 17, 2024

Record last verified: 2022-03

Locations

DE(1)