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| Name | Class |
|---|---|
| Dicentra Inc. | INDUSTRY |
| University of British Columbia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Acetyl-L-cysteine (NAC) | Active Comparator | 600 mg 1 capsule twice daily for 14 days |
|
| Echinacea purpurea | Active Comparator | 252 mg 1 capsule twice daily for 14 days |
|
| Curcumin | Active Comparator | 60 mg 3 capsules once daily for 14 days |
|
| Palmitoylethanolamide | Active Comparator | 400 mg 3 capsules once daily for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Acetyl-L-cysteine (NAC) | Dietary Supplement | Health Canada Natural Product Number (NPN) 80056946 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
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Inclusion Criteria:
Subjects meeting all of the following criteria will be considered for admission to the study:
Exclusion Criteria:
Subjects meeting any of the following criteria will not be eligible for the study:
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| Name | Affiliation | Role |
|---|---|---|
| Gurinder Raj, MD | dicentra | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dicentra | Toronto | Ontario | M5S2B7 | Canada |
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| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| C000718679 | Echinacea extract |
| D003474 | Curcumin |
| C005958 | palmidrol |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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8 participants assigned to Palmitoylethanolamide 8 participants assigned to Echinacea purpurea 8 participants assigned to Curcumin 8 participants assigned to N-Acetyl-L-cysteine
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| Echinacea purpurea | Dietary Supplement | Health Canada Natural Product Number (NPN) 80093896 |
|
| Curcumin | Dietary Supplement | Health Canada Natural Product Number (NPN) 80043455 |
|
| Palmitoylethanolamide | Dietary Supplement | Health Canada Natural Product Number (NPN) 80097472 |
|
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |