Clinical trial NCT04097808: Impact of the Source and Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
Official title: Impact of the Source and Polyphenol-containing Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bioavailability
Keywords: bioavailability
collagen peptides
polyphenols
Lead sponsor: Rousselot BVBA
Sponsor class: INDUSTRY
Collaborators: name: BioTeSys GmbH
First posted: 2019-09-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides.
timeFrame: pre dose and up to 6 hours post dose
measure: Peak plasma concentration after administration (Cmax) for hydroxyproline after single dose of the different collagen peptides
timeFrame: pre dose and up to 6 hours post dose
measure: Time to reach the maximum concentration of hydroxyproline (Tmax)
timeFrame: pre dose and up to 6 hours post dose
Secondary outcomes:
measure: Concentration-time of essential and not essential amino acids
timeFrame: pre dose and up to 6 hours post dose
Other outcomes:
Locations:
city: Esslingen
country: Germany
facility: BioTeSys GmbH
Study officials:
affiliation: BioTeSys GmbH
name: Daniel Menzel, MD
role: PRINCIPAL_INVESTIGATOR
References: