Comparison of relative bioavailability of three different animal and vegan source hydrolyzed collagen peptides
Conditions
Interventions
Group 1: collagen peptides (bovine), 5g, single dose (blood sampling over 6h)
wash out: 7 days
Cross-over design
Group 2: collagen peptides (fish), 5g, single dose (blood sampling over 6h)
Cross-over design
Group 3: Collagen peptides (vegan), 5g, single dose (blood sampling over 6h)
Cross-over design
Sponsors
Biotesys GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: • Participant is able and willing to sign the Informed Consent Form prior to screening evaluations • BMI: 19 - 28 kg/m2 • Non-smoker • Participant is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry and hematology
Exclusion criteria
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 • Application of corticoids (intravenously, orally or intraarticularly) and other immune-suppressing drug (within last 2 weeks) • For this study clinically relevant abnormal laboratory, 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 3 cups / day • History of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study • History of hypersensitivity to fish • Known HIV-infection, acute or chronic hepatitis B and C infection • If female: Known pregnancy, breast feeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1-3. • Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study • Anticipating any planned changes in lifestyle for the duration of the study • Participants considered inappropriate for the study by investigators, including ones who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the bioavailability of three different collagen products (two animal sources: fish and bovine, and one vegan source) after single dose in healthy participants. Plasma samples will be collected at baseline (pre) and at 0.5 h, 1 h, 2 h, 3 h, 4 h, and 6 h after product intake, and pharmacokinetic parameters of individual amino acids and selected di- and tripeptides will be analyzed. The primary endpoint is the iAUC0-6h (incremental area under the curve) of measured amino acids and di- and tripeptides. | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Cmax: maximum increase of plasma concentration of measured amino acids and di- and tripeptides. Tmax: time of maximum blood concentration of measured amino acids and di- and tripeptides. Additional: Adverse events will be assessed over the whole study period starting from screening. | — |
Countries
Germany
Contacts
Public ContactDaniel Menzel
Biotesys GmbH
Outcome results
None listed