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Completed

NCT Number: NCT04097808

Impact of the Source and 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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collagen Peptides

Dietary Supplement

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

Primary outcomes

  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 outcomes

  1. Concentration-time of essential and not essential amino acids

    Time frame: pre dose and up to 6 hours post dose

Sponsors and collaborators

Lead sponsor

Rousselot BVBA

Industry

Collaborators

  • BioTeSys GmbH

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Sep 20, 2019
Registry last updated
Apr 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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