Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Clermont-Ferrand

Clermont-Ferrand, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Keratin hydrolysate

Dietary 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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

BCF Life Sciences

Industry

Collaborators

Clinic'n'Cell
University Hospital, Clermont-Ferrand

Registry information

Official study title

Determination of the Biological Activity of Enriched Serums on Healthy Volunteers After Consumption of the Kera-Diet® Ingredient, CnC2024 - Kera-Diet®

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Sep 25, 2024
Registry last updated: Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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