Impact of the Source and Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects

Rousselot BVBA6 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Bioavailability

Interventions

collagen peptidesDIETARY_SUPPLEMENT

Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

BioTeSys GmbH

Esslingen am Neckar, Germany

Outcomes

Primary Outcomes

Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides.

Pharmakokinetic variable

Time frame: 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

Time frame: pre dose and up to 6 hours post dose

Time to reach the maximum concentration of hydroxyproline (Tmax)

Pharmakokinetic variable

Time frame: pre dose and up to 6 hours post dose

Secondary Outcomes

Concentration-time of essential and not essential amino acids

Time frame: pre dose and up to 6 hours post dose

Data from ClinicalTrials.gov

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