To Collect Enriched Human Serum Following Hydrolyzed Collagen Intake

Rousselot

Status

Completed

Conditions

Healthy Women

Treatments

Dietary Supplement: Collagen hydrolysate 5

Dietary Supplement: Collagen hydrolysate 4

Dietary Supplement: Collagen hydrolysate 3

Dietary Supplement: Collagen hydrolysate 2

Dietary Supplement: Collagen hydrolysate 1

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07195396

BTS2215/25

Details and patient eligibility

About

This randomized, double-blind, monocentric, five-way cross-over study aims to collect human serum and plasma samples at 1 and 2 hours after ingestion of hydrolyzed collagen peptides. The enriched sera will be used for ex vivo/ in vitro experiments on skin keratinocytes, fibroblasts, and other cell types to explore the beneficial effects of bioactive collagen peptides. Blood will also be analyzed for amino acid profiles and collagen-derived peptides.

Enrollment

3 patients

Sex

Female

Ages

35 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participant is able and willing to sign the Informed Consent Form prior to screening evaluations
Age: 35 - 45 years
Women
BMI: 19 - 25 kg/m2
Non-smoker
Participant is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology at screening

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, significant CVD events, 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
Low haemoglobin levels < 12 g/dL
Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during study (stable medication since > 3 months e.g. L-Thyroxin, blood pressure medication etc. allowed)
Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator's opinion would impact participant safety
Not willing to avoid intake of pain relievers e.g. Paracetamol or Ibuprofen 24h prior to study days
Participants with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study
History of hypersensitivity to fish
HIV-infection, acute or chronic hepatitis B and C infection
Known pregnancy, breast feeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1-5.
Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
Anticipating any planned changes in lifestyle for the duration of the study
Participants considered inappropriate for the study by investigators, including participants who are unable or unwilling to show compliance with the protocol

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

3 participants in 5 patient groups

Collagen hydrolysate 1

Active Comparator group

Description: