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

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

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.

Study Overview

• Status: Completed
• Conditions: Bioavailability
• Intervention / Treatment: Dietary supplement: collagen peptides

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Esslingen, Germany, 73728
    • BioTeSys GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

6

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Rousselot BVBA
• Collaborators: BioTeSys GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2019
• Primary Completion (Actual): October 25, 2019
• Study Completion (Actual): October 25, 2019

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 18, 2019
• First Posted (Actual): September 20, 2019

Study Record Updates

• Last Update Posted (Actual): April 30, 2020
• Last Update Submitted That Met QC Criteria: April 29, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: bioavailability; polyphenols; collagen peptides
• Other Study ID Numbers: BTS1362/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No