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

NCT06612866 | Active Not Recruiting

• 1 other identifier: 2024-A01011-46
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Kera-Diet treatment

OTHER

Dietary Supplement: Keratin hydrolysate

Interventions

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.

Kera-Diet treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Any type of vaccination within the past month.
• Alcohol consumption exceeding WHO standards (Sup. 3 drinks per day for men).
• 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).
• Medical and/or surgical history deemed incompatible with the trial by the investigator or their representative.

Sponsors & Collaborators

• BCF Life Sciences: lead
• Clinic'n'Cell: collaborator
• University Hospital, Clermont-Ferrand: collaborator

Study Sites (1)

University Hospital, Clermont-Ferrand

Clermont-Ferrand, France

Location

Study Officials

• Gisèle Pickering, PhD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 25, 2024
• Study Start: November 18, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)