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

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ClinicalTrials.gov Identifier: NCT04097808
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Collaborator:
BioTeSys GmbH
Information provided by (Responsible Party):
Rousselot BVBA

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.

Condition or disease Intervention/treatment Phase
Bioavailability Dietary Supplement: collagen peptides Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: double-blind study
Primary Purpose: Basic Science
Official Title: Impact of the Source and Polyphenol-containing Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
Estimated Study Start Date : September 20, 2019
Estimated Primary Completion Date : October 25, 2019
Estimated Study Completion Date : October 25, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

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.




Primary Outcome Measures :
  1. Area Under the Curve (AUC(0-6h)) for hydroxyproline after single dose of the different collagen peptides. [ Time Frame: pre dose and up to 6 hours post dose ]
    Pharmakokinetic variable

  2. Peak plasma concentration after administration (Cmax) for hydroxyproline after single dose of the different collagen peptides [ Time Frame: pre dose and up to 6 hours post dose ]
    Pharmakokinetic variable

  3. Time to reach the maximum concentration of hydroxyproline (Tmax) [ Time Frame: pre dose and up to 6 hours post dose ]
    Pharmakokinetic variable


Secondary Outcome Measures :
  1. Concentration-time of essential and not essential amino acids [ Time Frame: pre dose and up to 6 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097808


Contacts
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Contact: Christiane Schön +4971131057145 c.schoen@biotesys.de
Contact: Daniel Menzel, MD

Locations
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Germany
BioTeSys GmbH Recruiting
Esslingen, Germany, 73728
Contact: Christiane Schön    0711/351 38 36    kollagenstudie@biotesys.de   
Contact: Daniel Menzel, MD         
Sponsors and Collaborators
Rousselot BVBA
BioTeSys GmbH
Investigators
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Principal Investigator: Daniel Menzel, MD BioTeSys GmbH

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Responsible Party: Rousselot BVBA
ClinicalTrials.gov Identifier: NCT04097808     History of Changes
Other Study ID Numbers: BTS1362/19
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rousselot BVBA:
bioavailability
collagen peptides
polyphenols