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| Name | Class |
|---|---|
| BioTeSys GmbH | OTHER |
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The aim of this study is the comparison of the oral bioavailability of hydroxyproline, a key marker for collagen peptide intake, after ingestion of collagen peptides from different sources, sizes and together with different food matrices, either containing high or low levels of polyphenols.
The absorption (blood) of collagen peptides from bovine, fish and porcine source in different sizes and administered together with foods of different polyphenol content will be assessed. Pharmacokinetic parameters (AUC0-6h, Cmax and Tmax) after oral single dose administration will be determined to estimate the impact of different sources, different peptide sized any food matrix.
The following objectives will be evaluated exploratory by comparison of pharmacokinetic parameters from the concentration time curve of hydroxyproline, a key marker of collagen type I, between:
Additionally, concentration time curves of further amino acids will be assessed descriptively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| collagen peptide bovine high molecular weight-Water | Experimental | source: bovine; standardized to 10 g provided as single dose. Orally applied in water. |
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| collagen peptide bovine low molecular weight-Water | Experimental | source: bovine; standardized to 10 g provided as single dose. Orally applied in water. |
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| collagen peptide bovine low molecular weight- food matrix 1 | Experimental | source: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 1 |
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| collagen peptide bovine low molecular weight- food matrix 2 | Experimental | source: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 2 |
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| collagen peptide fish low molecular weight-Water | Experimental | source: fish; standardized to 10 g provided as single dose. Orally applied in water. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collagen peptides | Dietary Supplement | Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake. |
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| 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) | Pharmakokinetic variable | pre dose and up to 6 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration-time of essential and not essential amino acids | pre dose and up to 6 hours post dose |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Menzel, MD | BioTeSys GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
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The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
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double-blind study
| collagen peptide porcine low molecular weight-Water | Experimental | source: porcine; standardized to 10 g provided as single dose. Orally applied in water. |
|