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| Name | Class |
|---|---|
| BioTeSys GmbH | OTHER |
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This randomized, double-blind, monocentric, five-way cross-over study aims to collect human serum and plasma samples at 1 and 2 hours after ingestion of hydrolyzed collagen peptides. The enriched sera will be used for ex vivo/ in vitro experiments on skin keratinocytes, fibroblasts, and other cell types to explore the beneficial effects of bioactive collagen peptides. Blood will also be analyzed for amino acid profiles and collagen-derived peptides.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen hydrolysate 1 | Active Comparator | 10g single oral dose dissolved in water |
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| Collagen hydrolysate 2 | Active Comparator | 10g single oral dose dissolved in water |
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| Collagen hydrolysate 3 | Active Comparator | 10g single oral dose dissolved in water |
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| Collagen hydrolysate 4 | Active Comparator | 10g single oral dose dissolved in water |
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| Collagen hydrolysate 5 | Active Comparator | 10g single oral dose dissolved in water |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen hydrolysate 1 | Dietary Supplement | 10g single oral dose dissolved in water |
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| Measure | Description | Time Frame |
|---|---|---|
| collagen-derived di- and tripeptides | Change from baseline in serum concentration of collagen-derived di- and tripeptides (e.g., Pro-Hyp, Hyp-Gly in nanogram/mL) at 1 hour and 2 hours post-intake, measured by LC-MS/MS | 0-120 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Amino acids profile | Change from baseline in plasma amino acid profile (e.g., hydroxyproline, proline, glycine in microgram/mL) at 1 hour and 2 hours post-intake, measured by LC-MS/MS | 0-120 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Praneeth Reddy Kuninty, PhD | Rousselot BV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioTeSys GmbH | Esslingen am Neckar | 73728 | Germany |
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| Collagen hydrolysate 2 | Dietary Supplement | 10g single oral dose dissolved in water |
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| Collagen hydrolysate 3 | Dietary Supplement | 10g single oral dose dissolved in water |
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| Collagen hydrolysate 4 | Dietary Supplement | 10g single oral dose dissolved in water |
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| Collagen hydrolysate 5 | Dietary Supplement | 10g single oral dose dissolved in water |
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