Status:
RECRUITING
To Collect Enriched Human Serum Following Hydrolyzed Collagen Intake
Lead Sponsor:
Rousselot BVBA
Collaborating Sponsors:
BioTeSys GmbH
Conditions:
Healthy Women
Eligibility:
FEMALE
35-45 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 16 2026
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT07195396
Start Date
October 22 2025
End Date
April 16 2026
Last Update
December 4 2025
Active Locations (1)
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1
BioTeSys GmbH
Esslingen am Neckar, Germany, 73728