NCT05242718

Immune Diversity Response to Oral Dosing of Nutritional Health Products in Healthy Participants

A Open Label, Multi-Dose, Multi-Period Exploratory Clinical Trial to Test Immune Diversity Response to Oral Dosing of Approved Nutritional Health Products at Approved Doses to Healthy Volunteers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Immunoflex Therapeutics Inc. · Industry
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Accepted

Summary

A Phase IV, open-label, adaptive, 4-arm, multi-dose, single-centre, exploratory trial to assess the immune diversity response to oral administration of licensed Natural Health Products, in healthy adults, 60-70 years of age.

Detailed description

In this study, the effect of licensed Natural Health Products (NHP) on immune response-related/antibody diversity parameters will be measured. Immune repertoire changes will be measured by genetic sequencing of segments of mRNA in the participant's blood that correspond to the coding regions for the Complementarity Determining Region - 3 (CDR-3) of T- and B-cell surface receptors. CDR-3 receptor segments are the highly variable recognition elements of the T- and B-cell receptors responsible for the recognition of foreign cells and other entities. This recognition step is an early step in the adaptive immune response. Each of the four arms in the study contains 8 participants and each arm is assigned one NHP: Palmitoylethanolamide, or Echinacea purpurea, or Curcumin, or N-Acetyl-L-cysteine (NAC). Longitudinal changes in immune diversity and dynamics, as indicated by changes in the CDR-3 sequence information will be measured over five timeframes in an four week period. Baseline dynamics and diversity will be measured by comparing the results from participant visits 2 and 3. The impact of the NHP will be evident from comparing results between Visits 3 and 4. Finally, the impact of stopping the NHP dosing will be evident in comparing the results from Visit 5 to those of 4, 3, and 2. The techniques being used to analyze the sequence information are exploratory.

Conditions

• Immunity Disorders

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	N-Acetyl-L-cysteine (NAC)	Health Canada Natural Product Number (NPN) 80056946
DIETARY_SUPPLEMENT	Echinacea purpurea	Health Canada Natural Product Number (NPN) 80093896
DIETARY_SUPPLEMENT	Curcumin	Health Canada Natural Product Number (NPN) 80043455
DIETARY_SUPPLEMENT	Palmitoylethanolamide	Health Canada Natural Product Number (NPN) 80097472

Timeline

• Start date: 2021-01-10
• Primary completion: 2021-05-01
• Completion: 2021-05-20
• First posted: 2022-02-16
• Last updated: 2022-02-16

Locations

1 site across 1 country: Canada