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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Health Canada Natural Product Number (NPN) 80056946
Health Canada Natural Product Number (NPN) 80093896
Health Canada Natural Product Number (NPN) 80043455
Dicentra
Toronto, Ontario, Canada
Change in participants T & B cell Diversity Index (D50) from day 0 to day 29
D50 measures changes in frequency distributions of complementarity-determining region 3 (CDR3) in order to identify correlations between treatment and immune diversity. Diversity Index (D50) is a measure of the CDR3 diversity in the first half of the immune repertoire when looking at the frequency distributions. Additional bioinformatic analysis methods will be applied including Shannon Equitability Index and Antigen-specific Lymphocyte Identification by Clustering of Expanded Sequences.
Time frame: 4 weeks
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Health Canada Natural Product Number (NPN) 80097472