To Collect Enriched Human Serum Following Hydrolyzed Collagen Intake

NCT ID: NCT07195396

Last Updated: 2026-01-20

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2025-12-22

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Collagen hydrolysate 1

10g single oral dose dissolved in water

Group Type ACTIVE_COMPARATOR

Collagen hydrolysate 1

Intervention Type DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Collagen hydrolysate 2

10g single oral dose dissolved in water

Group Type ACTIVE_COMPARATOR

Collagen hydrolysate 2

Intervention Type DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Collagen hydrolysate 3

10g single oral dose dissolved in water

Group Type ACTIVE_COMPARATOR

Collagen hydrolysate 3

Intervention Type DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Collagen hydrolysate 4

10g single oral dose dissolved in water

Group Type ACTIVE_COMPARATOR

Collagen hydrolysate 4

Intervention Type DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Collagen hydrolysate 5

10g single oral dose dissolved in water

Group Type ACTIVE_COMPARATOR

Collagen hydrolysate 5

Intervention Type DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Interventions

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Collagen hydrolysate 1

10g single oral dose dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Collagen hydrolysate 2

10g single oral dose dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Collagen hydrolysate 3

10g single oral dose dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Collagen hydrolysate 4

10g single oral dose dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Collagen hydrolysate 5

10g single oral dose dissolved in water

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Collagen peptides collagen peptides collagen peptides collagen peptides collagen peptides

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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BioTeSys GmbH

OTHER

Sponsor Role collaborator

Rousselot BVBA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

Other Identifiers

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BTS2215/25

Identifier Type: -

Identifier Source: org_study_id

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