Status:
ACTIVE_NOT_RECRUITING
Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient
Lead Sponsor:
BCF Life Sciences
Collaborating Sponsors:
Clinic'n'Cell
University Hospital, Clermont-Ferrand
Conditions:
Healthy
Eligibility:
MALE
18-35 years
Phase:
NA
Brief 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 se...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06612866
Start Date
November 18 2024
End Date
May 1 2025
Last Update
January 10 2025
Active Locations (1)
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1
University Hospital, Clermont-Ferrand
Clermont-Ferrand, France