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

April 29, 2020 updated by: Rousselot BVBA

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Esslingen, Germany, 73728
        • BioTeSys GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: pre dose and up to 6 hours post dose
Pharmakokinetic variable
pre dose and up to 6 hours post dose
Time to reach the maximum concentration of hydroxyproline (Tmax)
Time Frame: pre dose and up to 6 hours post dose
Pharmakokinetic variable
pre dose and up to 6 hours post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Concentration-time of essential and not essential amino acids
Time Frame: pre dose and up to 6 hours post dose
pre dose and up to 6 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rousselot BVBA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioTeSys GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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