Completed

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

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What is being tested

N-Acetyl-L-cysteine (NAC)

+ Echinacea purpurea

+ Curcumin

Dietary Supplement
Who is being recruted

Immune System Diseases

From 60 to 70 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 2021
See protocol details

Summary

Principal SponsorImmunoflex Therapeutics Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 10, 2021

Actual date on which the first participant was enrolled.

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.

Official TitleA 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
NCT05242718
Principal SponsorImmunoflex Therapeutics Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 60 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Immune System Diseases

Criteria

Inclusion Criteria: * Subjects meeting all of the following criteria will be considered for admission to the study: 1. Healthy subjects between 60-70 years of age. 2. Availability of the subject for one of the forecasted study periods and willingness of the subject to adhere to protocol requirements, as evidenced by a signed Informed Consent Form 3. Have a BMI between18.5-29.9 4. Agrees not to use any over the counter, prescription, health supplement or dietary supplement from screening until the end of the study period. 5. Agrees to refrain from vaccinations throughout the study period. 6. Able to maintain their current routine level of physical activities throughout the study period 7. Willing and able to agree to the requirements and restrictions of this study (including but not limited to: not consuming more than 2 standard alcoholic beverages a day \[A standard alcoholic beverage is defined as 12 ounces of beer, five (5) ounces of wine, or 1.5 ounces of liquor\]), not consuming cannabis products of any type. 8. In good health as determined by lack of clinically significant abnormalities in health assessments (history, physical examination, laboratory tests) performed at screening as judged by the physician. 9. Women will be those without child bearing potential Exclusion Criteria: * Subjects meeting any of the following criteria will not be eligible for the study: 1. Have a known sensitivity or allergy to any of the study products 2. Self-reported smokers 3. Receipt or use of an investigational product in another research study within 30 days prior to Baseline (Visit 2) or currently participating in another research study 4. Receipt of a vaccination of any type within 60 days prior to the baseline visit. 5. Difficulty with venipuncture and/or poor venous access 6. Any major surgery within 1 year of study drug administration 7. Anticipated major surgeries or major life events (major travel or change in lifestyle conditions) forecast to occur during the anticipated study periods 8. Blood transfusion within 8 weeks of study drug administration 9. Donation of blood or plasma to a blood bank or clinical study within 8 weeks of study drug administration 10. Any clinically significant abnormalities in vital signs, as judged by the investigator. 11. Hypertension or on blood pressure lowering medication 12. Subjects with medical conditions that might interfere with participation in the study or interpretation of the study results. These include serious chronic diseases such as diabetes, neurologic or psychiatric disease (including any previous suicidal symptoms or suicide attempts), cardiovascular disease, gastrointestinal disease, pulmonary disease, cancer, autoimmune diseases, immunodeficiencies, hepatic or renal diseases. 13. History of prior significant cardiovascular disease, coronary artery disease, cardiovascular surgery, significant valvular disease, heart failure, arrhythmias, sick sinus syndrome or stroke 14. History of clinically significant cerebrovascular, metabolic, pulmonary, neurological, hematological, autoimmune, endocrine disorders, including individuals with Type I or Type II diabetes, or other clinically significant medical condition that, in the opinion of the Investigator, may preclude safe study participation 15. History of immune disorder (such as HIV/AIDS), hepatitis B or hepatitis C, or positive immune disorder diagnosis 16. History of alcohol or substance abuse in the 12 months prior to screening 17. History of cannabis product use, including Cannabidiol (CBD), in the 3 months prior to screening 18. Any other medical or social condition that, in the judgment of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data or otherwise interfere with achieving the study objectives.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
600 mg 1 capsule twice daily for 14 days

Group II

Active Comparator
252 mg 1 capsule twice daily for 14 days

Group III

Active Comparator
60 mg 3 capsules once daily for 14 days

Group IV

Active Comparator
400 mg 3 capsules once daily for 14 days

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Dicentra

Toronto, CanadaOpen Dicentra in Google Maps
CompletedOne Study Center