Bioavailability
Conditions
Keywords
bioavailability, collagen peptides, polyphenols
Brief summary
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.
Detailed description
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: * different sources of collagen peptides (bovine, fish, porcine) * different sizes of collagen peptides from cattle * food matrices impact on uptake of bovine collagen peptides (dissolved in water vs. food matrix 1 vs. food matrix 2). Additionally, concentration time curves of further amino acids will be assessed descriptively.
Interventions
DIETARY_SUPPLEMENTcollagen peptides
Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.
Sponsors
BioTeSys GmbH
Rousselot BVBA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
double-blind study
Intervention model description
The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Main Inclusion Criteria: * Subject is able and willing to sign the Informed Consent Form prior to screening evaluations * Sex: female and male (50 % of each gender) * Age: 18-50 years * BMI ≥19 and ≤28 kg/m² * Nonsmoker Main
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.) * 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) * Blood donation within 1 month prior to study start or during study * Regular intake of drugs or supplements possibly interfering with this study (Glucosamine, chondroitin sulfate, hyaluronic acid, omega-3, folic acid, curcumin/turmeric, Boswellia serrata, collagen, Vitamin D) within 2 weeks prior to study start or during study * Intake of anticoagulants like Heparin, Marcumar etc. * Coffee consumption \>3 cups / day * History of hypersensitivity to fish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach the maximum concentration of hydroxyproline (Tmax) | pre dose and up to 6 hours post dose | Pharmakokinetic variable |
| Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides. | pre dose and up to 6 hours post dose | Pharmakokinetic variable |
| Peak plasma concentration after administration (Cmax) for hydroxyproline after single dose of the different collagen peptides | pre dose and up to 6 hours post dose | Pharmakokinetic variable |
Secondary
| Measure | Time frame |
|---|---|
| Concentration-time of essential and not essential amino acids | pre dose and up to 6 hours post dose |
Countries
Germany
Outcome results
None listed