Status:
COMPLETED
Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects
Lead Sponsor:
Rousselot BVBA
Collaborating Sponsors:
BioTeSys GmbH
Conditions:
Healthy
Eligibility:
All Genders
18-50 years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT05252962
Start Date
November 26 2021
End Date
May 17 2023
Last Update
December 17 2024
Active Locations (1)
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1
BioTeSys GmbH
Esslingen am Neckar, Germany, 73728