To Collect Enriched Human Serum Following Hydrolyzed Collagen Intake
NCT ID: NCT07195396
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
3 participants
INTERVENTIONAL
2025-10-22
2025-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Collagen hydrolysate 1
10g single oral dose dissolved in water
Collagen hydrolysate 1
10g single oral dose dissolved in water
Collagen hydrolysate 2
10g single oral dose dissolved in water
Collagen hydrolysate 2
10g single oral dose dissolved in water
Collagen hydrolysate 3
10g single oral dose dissolved in water
Collagen hydrolysate 3
10g single oral dose dissolved in water
Collagen hydrolysate 4
10g single oral dose dissolved in water
Collagen hydrolysate 4
10g single oral dose dissolved in water
Collagen hydrolysate 5
10g single oral dose dissolved in water
Collagen hydrolysate 5
10g single oral dose dissolved in water
Interventions
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Collagen hydrolysate 1
10g single oral dose dissolved in water
Collagen hydrolysate 2
10g single oral dose dissolved in water
Collagen hydrolysate 3
10g single oral dose dissolved in water
Collagen hydrolysate 4
10g single oral dose dissolved in water
Collagen hydrolysate 5
10g single oral dose dissolved in water
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
45 Years
FEMALE
Yes
Sponsors
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BioTeSys GmbH
OTHER
Rousselot BVBA
INDUSTRY
Responsible Party
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Principal Investigators
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Praneeth Reddy Kuninty, PhD
Role: PRINCIPAL_INVESTIGATOR
Rousselot BV
Locations
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BioTeSys GmbH
Esslingen am Neckar, , Germany
Countries
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Other Identifiers
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BTS2215/25
Identifier Type: -
Identifier Source: org_study_id
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