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

NCT ID: NCT04097808

Last Updated: 2020-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-20
• Study Completion Date: 2019-10-25

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.

Conditions

Bioavailability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

collagen peptide bovine high molecular weight-Water

source: bovine; standardized to 10 g provided as single dose. Orally applied in water.

Group Type: EXPERIMENTAL

collagen peptides

Intervention Type: DIETARY_SUPPLEMENT

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

collagen peptide bovine low molecular weight-Water

source: bovine; standardized to 10 g provided as single dose. Orally applied in water.

Group Type: EXPERIMENTAL

collagen peptides

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

collagen peptides

Intervention Type: DIETARY_SUPPLEMENT

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

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

Group Type: EXPERIMENTAL

collagen peptides

Intervention Type: DIETARY_SUPPLEMENT

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

collagen peptide fish low molecular weight-Water

source: fish; standardized to 10 g provided as single dose. Orally applied in water.

Group Type: EXPERIMENTAL

collagen peptides

Intervention Type: DIETARY_SUPPLEMENT

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

collagen peptide porcine low molecular weight-Water

source: porcine; standardized to 10 g provided as single dose. Orally applied in water.

Group Type: EXPERIMENTAL

collagen peptides

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

collagen peptides

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BioTeSys GmbH

OTHER

Sponsor Role: collaborator

Rousselot BVBA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Menzel, MD

Role: PRINCIPAL_INVESTIGATOR

BioTeSys GmbH

Locations

BioTeSys GmbH

Esslingen am Neckar, , Germany

Countries

Germany

Other Identifiers

BTS1362/19

Identifier Type: -

Identifier Source: org_study_id