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

NCT04097808 | Completed

• 1 other identifier: BTS1362/19
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Keywords

bioavailability; collagen peptides; polyphenols

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Time to reach the maximum concentration of hydroxyproline (Tmax)

  Pharmakokinetic variable

  pre dose and up to 6 hours post dose

Secondary Outcomes (1)

• Concentration-time of essential and not essential amino acids

  pre dose and up to 6 hours post dose

Study Arms (6)

collagen peptide bovine high molecular weight-Water

EXPERIMENTAL

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

Dietary Supplement: collagen peptides

collagen peptide bovine low molecular weight-Water

EXPERIMENTAL

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

Dietary Supplement: collagen peptides

collagen peptide bovine low molecular weight- food matrix 1

EXPERIMENTAL

source: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 1

Dietary Supplement: collagen peptides

collagen peptide bovine low molecular weight- food matrix 2

EXPERIMENTAL

source: bovine; standardized to 10 g provided as single dose. Orally applied in Food matrix 2

Dietary Supplement: collagen peptides

collagen peptide fish low molecular weight-Water

EXPERIMENTAL

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

Dietary Supplement: collagen peptides

collagen peptide porcine low molecular weight-Water

EXPERIMENTAL

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

Dietary Supplement: collagen peptides

Interventions

collagen peptides 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 high molecular weight-Water; collagen peptide bovine low molecular weight- food matrix 1; collagen peptide bovine low molecular weight- food matrix 2; collagen peptide bovine low molecular weight-Water; collagen peptide fish low molecular weight-Water; collagen peptide porcine low molecular weight-Water

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rousselot BVBA: lead
• BioTeSys GmbH: collaborator

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

Study Officials

• Daniel Menzel, MD

  BioTeSys GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind study
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 20, 2019
• Study Start: September 20, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: April 30, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)