HealthyNCT06612866
Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient
A study testing Keratin hydrolysate in people with Healthy, run by BCF Life Sciences at 1 site in France.
Trial summary
The main objective of this study is, after collecting serum enriched with metabolites of interest resulting from the ingestion of the Kera-Diet® food supplement, to determine the influence of these sera enriched with circulating metabolites (versus naïve sera) on the behavior of human cell cultures, placed under… Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Keratin hydrolysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 18 Nov 2024to May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Main inclusion Criteria:
- Liver function tests within reference norms.
- Kidney function tests within reference norms.
- Complete blood count (CBC) within reference norms.
- C-reactive protein (CRP) within reference norms.
- Blood pressure compatible with study requirements.
- Non-smoker or occasional smoker (max 5 cigarettes/day or max 10 ml per week of e-liquid with a nicotine concentration of 3 mg/ml).
- Max 5 hours of intense sports per week.
- Weight ≥ 60 kg.
- BMI between 20 and 28 kg/m² (exclusive).
Main exclusion Criteria:
- Any type of vaccination within the past month.
- Alcohol consumption exceeding WHO standards (Sup. 3 drinks per day for men).
- Ongoing treatment (medication, dietary supplement, or probiotic) and within the four weeks prior to inclusion.
- Known pathology (including seasonal).
- Allergy to the study product, particularly to keratin or certain amino acids.
- Individuals following a diet unsuitable for the study (e.g., vegetarian, vegan, or plant-based diets).
- Change in eating habits within the 4 weeks prior to inclusion.
- Medical and/or surgical history deemed incompatible with the trial by the investigator or their representative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient, CnC2024 - Kera-Diet®
The main objective of this study is, after collecting serum enriched with metabolites of interest resulting from the ingestion of the Kera-Diet® food supplement, to determine the influence of these sera enriched with circulating metabolites (versus naïve sera) on the behavior of human cell cultures, placed under stress conditions or not, in order to evaluate the benefit of these metabolites in maintaining cellular functions.
- Conditions
- Healthy
- Being tested
- Keratin hydrolysate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keratin hydrolysateDietary supplement
The clinical study will be conducted in two phases. The first phase will aim at characterizing the metabolites present in human serum after consumption of the Kera-Diet® ingredient and at determining the overall absorption peak of the tested ingredient. The second phase will involve collecting sera enriched with metabolites at the absorption peak, following the ingestion of the ingredient. Subsequently, the final objective will be to characterize the influence of these sera enriched with metabolites of interest on the behavior of human skin cell and intestinal epithelial cell cultures.
| Study group | Role | What they receive |
|---|---|---|
| Kera-Diet treatment | Other | Not described Receives: Dietary Supplement: Keratin hydrolysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the influence of human serums enriched with circulating metabolites on human cell cultures
Determination of the influence of human serums enriched with circulating metabolites (versus naïve serums) on the behavior of human cell cultures exposed or not to stress conditions in order to evaluate the benefit of these metabolites in maintaining cellular functions.
Measured: Determination of the absorption peak: kinetics will be determined by a blood draw at different time points (T0, T5, T10, T20, T30, T45, T60, T80, T100, T120, T140, T180, T240 minutes) over the 4 hours following the ingestion of the study product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start18 Nov 2024
- Primary completionJan 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BCF Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinic'n'Cell, University Hospital, Clermont-Ferrand
- Responsible party
- Sponsor
- Investigators
- Gisèle Pickering, PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612866
- Sponsor's protocol ID
- 2024-A01011-46
- Status last verified
- Jan 2025
- First submitted
- 23 Sep 2024
- Last updated
- 10 Jan 2025
- 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 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient, CnC2024 - Kera-Diet®
- ClinicalTrials.gov ID
- NCT06612866
- Acronym / sponsor ID
- 2024-A01011-46
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- BCF Life SciencesIndustry (pharma, biotech, devices)
- Collaborators
- Clinic'n'Cell, University Hospital, Clermont-Ferrand
- Study start
- 18 Nov 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 25 Sep 2024 (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.
The main objective of this study is, after collecting serum enriched with metabolites of interest resulting from the ingestion of the Kera-Diet® food supplement, to determine the influence of these sera enriched with circulating metabolites (versus naïve sera) on the behavior of human cell cultures, placed under stress conditions or not, in order to evaluate the benefit of these metabolites in maintaining cellular functions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kera-Diet treatment | Other | Dietary Supplement: Keratin hydrolysate |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Keratin hydrolysateThe clinical study will be conducted in two phases. The first phase will aim at characterizing the metabolites present in human serum after consumption of the Kera-Diet® ingredient and at determining the overall absorption peak of the tested ingredient. The second phase will involve collecting sera enriched with metabolites at the absorption peak, following the ingestion of the ingredient. Subsequently, the final objective will be to characterize the influence of these sera enriched with metabolites of interest on the behavior of human skin cell and intestinal epithelial cell cultures. | Dietary supplement | Kera-Diet treatment |
Primary outcome
Determination of the influence of human serums enriched with circulating metabolites on human cell cultures
Time frame: Determination of the absorption peak: kinetics will be determined by a blood draw at different time points (T0, T5, T10, T20, T30, T45, T60, T80, T100, T120, T140, T180, T240 minutes) over the 4 hours following the ingestion of the study product
Determination of the influence of human serums enriched with circulating metabolites (versus naïve serums) on the behavior of human cell cultures exposed or not to stress conditions in order to evaluate the benefit of these metabolites in maintaining cellular functions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- 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.
Gisèle Pickering, PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keratin hydrolysate in people with Healthy, run by BCF Life Sciences at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Determination of the influence of human serums enriched with circulating metabolites on human cell cultures (time frame: Determination of the absorption peak: kinetics will be determined by a blood draw at different time points (T0, T5, T10, T20, T30, T45, T60, T80, T100, T120, T140, T180, T240 minutes) over the 4 hours following the ingestion of the study product). 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 10 Jan 2025.