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

Study Overview
=================
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.

Official Title
-----------------
Impact of the Source and Polyphenol-containing Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects

Conditions
-----------------
Bioavailability

Intervention / Treatment
-----------------
* Dietary Supplement: collagen peptides


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: collagen peptide bovine high molecular weight-Water<br>source: bovine; standardized to 10 g provided as single dose. Orally applied in water. | Dietary Supplement: collagen peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|
| Experimental: collagen peptide bovine low molecular weight-Water<br>source: bovine; standardized to 10 g provided as single dose. Orally applied in water. | Dietary Supplement: collagen peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|
| Experimental: collagen peptide bovine low molecular weight- food matrix 1<br>source: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 1 | Dietary Supplement: collagen peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|
| Experimental: collagen peptide bovine low molecular weight- food matrix 2<br>source: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 2 | Dietary Supplement: collagen peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|
| Experimental: collagen peptide fish low molecular weight-Water<br>source: fish; standardized to 10 g provided as single dose. Orally applied in water. | Dietary Supplement: collagen peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|
| Experimental: collagen peptide porcine low molecular weight-Water<br>source: porcine; standardized to 10 g provided as single dose. Orally applied in water. | Dietary Supplement: collagen peptides<br>* Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides. | Pharmakokinetic variable | 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 | pre dose and up to 6 hours post dose | 
| Time to reach the maximum concentration of hydroxyproline (Tmax) | Pharmakokinetic variable | pre dose and up to 6 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration-time of essential and not essential amino acids |  | pre dose and up to 6 hours post dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bioavailability, collagen peptides, polyphenols