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

Rousselot

Status: Completed

Conditions: Bioavailability

Treatments: Dietary Supplement: collagen peptides

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04097808

BTS1362/19

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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6 participants in 6 patient groups

collagen peptide bovine high molecular weight-Water

Experimental group

Description:

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

Treatment:

Dietary Supplement: collagen peptides

collagen peptide bovine low molecular weight-Water

Experimental group

Description:

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

Treatment:

Dietary Supplement: collagen peptides

collagen peptide bovine low molecular weight- food matrix 1

Experimental group

Description:

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

Treatment:

Dietary Supplement: collagen peptides

collagen peptide bovine low molecular weight- food matrix 2

Experimental group

Description:

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

Treatment:

Dietary Supplement: collagen peptides

collagen peptide fish low molecular weight-Water

Experimental group

Description:

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

Treatment:

Dietary Supplement: collagen peptides

collagen peptide porcine low molecular weight-Water

Experimental group

Description:

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

Treatment:

Dietary Supplement: collagen peptides