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

Bioavailability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04097808
• Other study ID #: BTS1362/19
• Status: Completed
• Phase: N/A
• Start date: September 20, 2019
• Est. completion date: October 25, 2019

Study information

• Verified date: September 2019
• Source: Rousselot BVBA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bioavailability

Intervention

Dietary Supplement:
• collagen peptides
Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.

Locations

Country	Name	City	State
Germany	BioTeSys GmbH	Esslingen

Sponsors (2)

Lead Sponsor	Collaborator
Rousselot BVBA	BioTeSys GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Time to reach the maximum concentration of hydroxyproline (Tmax)	Pharmakokinetic variable	pre dose and up to 6 hours post dose
Secondary	Concentration-time of essential and not essential amino acids		pre dose and up to 6 hours post dose