Healthy WomenNCT07195396
To Collect Enriched Human Serum Following Hydrolyzed Collagen Intake
A study testing Collagen hydrolysate 1, Collagen hydrolysate 2 and Collagen hydrolysate 3 in people with Healthy Women, run by Rousselot BVBA at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Collagen hydrolysate 1, Collagen hydrolysate 2 and Collagen hydrolysate 3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteGermany
- Study dates
- 22 Oct 2025to 22 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Moncentric, Cross-over Study to Collect Human Serum After Ingestion of Hydrolyzed Collagen Peptides.
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.
- Conditions
- Healthy Women
- Being tested
- Collagen hydrolysate 1, Collagen hydrolysate 2, Collagen hydrolysate 3, Collagen hydrolysate 4, Collagen hydrolysate 5
- Keywords
- collagen peptides, collagen hydrolysates, enriched human serum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collagen hydrolysate 1Dietary supplement
Also called Collagen peptides
10g single oral dose dissolved in water
Collagen hydrolysate 2Dietary supplement
Also called collagen peptides
10g single oral dose dissolved in water
Collagen hydrolysate 3Dietary supplement
Also called collagen peptides
10g single oral dose dissolved in water
Collagen hydrolysate 4Dietary supplement
Also called collagen peptides
10g single oral dose dissolved in water
Collagen hydrolysate 5Dietary supplement
Also called collagen peptides
10g single oral dose dissolved in water
| Study group | Role | What they receive |
|---|---|---|
| Collagen hydrolysate 1 | Active comparator | 10g single oral dose dissolved in water Receives: Dietary Supplement: Collagen hydrolysate 1 |
| Collagen hydrolysate 2 | Active comparator | 10g single oral dose dissolved in water Receives: Dietary Supplement: Collagen hydrolysate 2 |
| Collagen hydrolysate 3 | Active comparator | 10g single oral dose dissolved in water Receives: Dietary Supplement: Collagen hydrolysate 3 |
| Collagen hydrolysate 4 | Active comparator | 10g single oral dose dissolved in water Receives: Dietary Supplement: Collagen hydrolysate 4 |
| Collagen hydrolysate 5 | Active comparator | 10g single oral dose dissolved in water Receives: Dietary Supplement: Collagen hydrolysate 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
collagen-derived di- and tripeptides
Change from baseline in serum concentration of collagen-derived di- and tripeptides (e.g., Pro-Hyp, Hyp-Gly in nanogram/mL) at 1 hour and 2 hours post-intake, measured by LC-MS/MS
Measured: 0-120 minutes
Secondary outcomes (1)
Amino acids profile
Change from baseline in plasma amino acid profile (e.g., hydroxyproline, proline, glycine in microgram/mL) at 1 hour and 2 hours post-intake, measured by LC-MS/MS
Measured: 0-120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start22 Oct 2025
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rousselot BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Responsible party
- Sponsor
- Investigators
- Praneeth Reddy Kuninty, PhD, Principal investigator, Rousselot BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195396
- Sponsor's protocol ID
- BTS2215/25
- Status last verified
- Jan 2026
- First submitted
- 12 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Moncentric, Cross-over Study to Collect Human Serum After Ingestion of Hydrolyzed Collagen Peptides.
- ClinicalTrials.gov ID
- NCT07195396
- Acronym / sponsor ID
- BTS2215/25
- Conditions
- Healthy Women
- Keywords
- collagen peptides, collagen hydrolysates, enriched human serum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rousselot BVBAIndustry (pharma, biotech, devices)
- Collaborators
- BioTeSys GmbH
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Collagen hydrolysate 1 | Active comparator | Dietary Supplement: Collagen hydrolysate 110g single oral dose dissolved in water |
| Collagen hydrolysate 2 | Active comparator | Dietary Supplement: Collagen hydrolysate 210g single oral dose dissolved in water |
| Collagen hydrolysate 3 | Active comparator | Dietary Supplement: Collagen hydrolysate 310g single oral dose dissolved in water |
| Collagen hydrolysate 4 | Active comparator | Dietary Supplement: Collagen hydrolysate 410g single oral dose dissolved in water |
| Collagen hydrolysate 5 | Active comparator | Dietary Supplement: Collagen hydrolysate 510g single oral dose dissolved in water |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collagen hydrolysate 1Also: Collagen peptides10g single oral dose dissolved in water | Dietary supplement | Collagen hydrolysate 1 |
| Collagen hydrolysate 2Also: collagen peptides10g single oral dose dissolved in water | Dietary supplement | Collagen hydrolysate 2 |
| Collagen hydrolysate 3Also: collagen peptides10g single oral dose dissolved in water | Dietary supplement | Collagen hydrolysate 3 |
| Collagen hydrolysate 4Also: collagen peptides10g single oral dose dissolved in water | Dietary supplement | Collagen hydrolysate 4 |
| Collagen hydrolysate 5Also: collagen peptides10g single oral dose dissolved in water | Dietary supplement | Collagen hydrolysate 5 |
Primary outcome
collagen-derived di- and tripeptides
Time frame: 0-120 minutes
Change from baseline in serum concentration of collagen-derived di- and tripeptides (e.g., Pro-Hyp, Hyp-Gly in nanogram/mL) at 1 hour and 2 hours post-intake, measured by LC-MS/MS
1 secondary outcome
Amino acids profile
Time frame: 0-120 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Praneeth Reddy Kuninty, PhD principal investigator
Rousselot BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collagen hydrolysate 1, Collagen hydrolysate 2 and Collagen hydrolysate 3 in people with Healthy Women, run by Rousselot BVBA at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collagen-derived di- and tripeptides (time frame: 0-120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.