Investigation of the Bioavailability of Marine Based Collagen Peptides in Healthy Subjects

Rousselot

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Collagen Peptides

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05252962

BTS1786/21

Details and patient eligibility

About

The aim of this study is to evaluate the relative bioavailability of Peptan® Type I collagen peptides from different marine origin (different fish sources, production process and molecular weight) in healthy human subjects.

Full description

The aim of this study is to evaluate the relative bioavailability of different Peptan® Type I collagen peptides in healthy human subjects. The pharmacokinetic parameters AUC0-6h, Cmax and Tmax will be determined from the concentration-time curves of characteristic collagen markers (e.g. hydroxyproline, proline, glycine, di- and tripeptides together with further amino acids) after oral single dose administration.

The following objectives will be evaluated by comparison of pharmacokinetic parameters between the products:

• The impact of different production processes
• The impact of size of collagen peptides
• The impact of different fish sources

Enrollment: 14 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
• Age: 18 - 50 years
• Healthy men and women
• BMI: 19 - 28 kg/m2
• Non-smoker

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.)
• A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure
• Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
• For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening
• Blood donation within 1 month prior to study start or during study
• "Extreme dietary regimes": vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal for men
• Intake of anticoagulants like Heparin, Marcumar etc.
• Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during study
• History of hypersensitivity to fish

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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14 participants in 4 patient groups

marine collagen peptide production process I

Experimental group

Description:

standardized to 10 g provided as single dose. Orally applied in water.

Treatment:

Dietary Supplement: Collagen Peptides

marine collagen peptide production process II

Experimental group

Description:

standardized to 10 g provided as single dose. Orally applied in water.

Treatment:

Dietary Supplement: Collagen Peptides

marine collagen peptide fish source I

Experimental group

Description:

standardized to 10 g provided as single dose. Orally applied in water.

Treatment:

Dietary Supplement: Collagen Peptides

marine collagen peptide fish source II

Experimental group

Description:

standardized to 10 g provided as single dose. Orally applied in water.

Treatment:

Dietary Supplement: Collagen Peptides