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NCT05252962

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

NCT ID: NCT05252962

Last Updated: 2024-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-26

Study Completion Date

2023-05-17

Brief Summary

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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

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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

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

double-blind

Study Groups

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marine collagen peptide production process I

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

Group Type EXPERIMENTAL

Collagen Peptides

Intervention Type DIETARY_SUPPLEMENT

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

marine collagen peptide production process II

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

Group Type EXPERIMENTAL

Collagen Peptides

Intervention Type DIETARY_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 I

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

Group Type EXPERIMENTAL

Collagen Peptides

Intervention Type DIETARY_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 II

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

Group Type EXPERIMENTAL

Collagen Peptides

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Collagen Peptides

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioTeSys GmbH

OTHER

Sponsor Role collaborator

Rousselot BVBA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicoletta Virgilio, PhD

Role: STUDY_DIRECTOR

RousselotBVBA

Locations

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BioTeSys GmbH

Esslingen am Neckar, , Germany

Site Status

Countries

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Germany

Other Identifiers

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BTS1786/21

Identifier Type: -

Identifier Source: org_study_id