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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05252962
• Other study ID #: BTS1786/21
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 26, 2021
• Est. completion date: May 17, 2023

Study information

• Verified date: March 2022
• Source: Rousselot BVBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 14
• Est. completion date: May 17, 2023
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Collagen Peptides
Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.

Locations

Country	Name	City	State
Germany	BioTeSys GmbH	Esslingen

Sponsors (2)

Lead Sponsor	Collaborator
Rousselot BVBA	BioTeSys GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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