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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Keratin hydrolysate

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • University Hospital, Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Kera-Diet treatment

Dietary supplement: Keratin hydrolysate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Collaborators and Investigators

• Sponsor: BCF Life Sciences
• Collaborators: University Hospital, Clermont-Ferrand; Clinic'n'Cell
• Investigators: Principal Investigator: Gisèle Pickering, PhD, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 23, 2024
• First Posted (Actual): September 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024-A01011-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No