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

Study Overview
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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

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Collagen Peptides


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: marine collagen peptide production process I<br>standardized to 10 g provided as single dose. Orally applied in water. | Dietary Supplement: Collagen Peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|
| Experimental: marine collagen peptide production process II<br>standardized to 10 g provided as single dose. Orally applied in water. | Dietary Supplement: Collagen Peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|
| Experimental: marine collagen peptide fish source I<br>standardized to 10 g provided as single dose. Orally applied in water. | Dietary Supplement: Collagen Peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|
| Experimental: marine collagen peptide fish source II<br>standardized to 10 g provided as single dose. Orally applied in water. | Dietary Supplement: Collagen Peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |