Immunity DisordersNCT05242718
Immune Diversity Response to Oral Dosing of Nutritional Health Products in Healthy Participants
A study testing N-Acetyl-L-cysteine (NAC), Echinacea purpurea and Curcumin in people with Immunity Disorders, run by Immunoflex Therapeutics Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunity Disorders
- What is being tested?
- N-Acetyl-L-cysteine (NAC), Echinacea purpurea and Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jan 2021to 20 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects meeting all of the following criteria will be considered for admission to the study:
- Healthy subjects between 60-70 years of age.
- 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
- Have a BMI between18.5-29.9
- Agrees not to use any over the counter, prescription, health supplement or dietary supplement from screening until the end of the study period.
- Agrees to refrain from vaccinations throughout the study period.
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- Able to maintain their current routine level of physical activities throughout the study period
- 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.
- 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.
- Women will be those without child bearing potential
Who cannot join
- Subjects meeting any of the following criteria will not be eligible for the study:
- Have a known sensitivity or allergy to any of the study products
- Self-reported smokers
- 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
- Receipt of a vaccination of any type within 60 days prior to the baseline visit.
- Difficulty with venipuncture and/or poor venous access
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- Any major surgery within 1 year of study drug administration
- Anticipated major surgeries or major life events (major travel or change in lifestyle conditions) forecast to occur during the anticipated study periods
- Blood transfusion within 8 weeks of study drug administration
- Donation of blood or plasma to a blood bank or clinical study within 8 weeks of study drug administration
- Any clinically significant abnormalities in vital signs, as judged by the investigator.
- Hypertension or on blood pressure lowering medication
- 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.
- History of prior significant cardiovascular disease, coronary artery disease, cardiovascular surgery, significant valvular disease, heart failure, arrhythmias, sick sinus syndrome or stroke
- 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
- History of immune disorder (such as HIV/AIDS), hepatitis B or hepatitis C, or positive immune disorder diagnosis
- History of alcohol or substance abuse in the 12 months prior to screening
- History of cannabis product use, including Cannabidiol (CBD), in the 3 months prior to screening
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- N-Acetyl-L-cysteine (NAC), Echinacea purpurea, Curcumin, Palmitoylethanolamide
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetyl-L-cysteine (NAC)Dietary supplement
Also called NAC
Health Canada Natural Product Number (NPN) 80056946
Echinacea purpureaDietary supplement
Health Canada Natural Product Number (NPN) 80093896
CurcuminDietary supplement
Health Canada Natural Product Number (NPN) 80043455
PalmitoylethanolamideDietary supplement
Health Canada Natural Product Number (NPN) 80097472
| Study group | Role | What they receive |
|---|---|---|
| N-Acetyl-L-cysteine (NAC) | Active comparator | 600 mg 1 capsule twice daily for 14 days Receives: Dietary Supplement: N-Acetyl-L-cysteine (NAC) |
| Echinacea purpurea | Active comparator | 252 mg 1 capsule twice daily for 14 days Receives: Dietary Supplement: Echinacea purpurea |
| Curcumin | Active comparator | 60 mg 3 capsules once daily for 14 days Receives: Dietary Supplement: Curcumin |
| Palmitoylethanolamide | Active comparator | 400 mg 3 capsules once daily for 14 days Receives: Dietary Supplement: Palmitoylethanolamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2022
- Study start10 Jan 2021
- Primary completion1 May 2021
- Study completion20 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunity DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 8 participants assigned to Palmitoylethanolamide 8 participants assigned to Echinacea purpurea 8 participants assigned to Curcumin 8 participants assigned to N-Acetyl-L-cysteine
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Immunoflex Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc., University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Gurinder Raj, MD, Principal investigator, dicentra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05242718
- Sponsor's protocol ID
- IMFX.CT1.002
- Status last verified
- Feb 2022
- First submitted
- 13 Jan 2022
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05242718
- Acronym / sponsor ID
- IMFX.CT1.002
- Conditions
- Immunity Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Immunoflex Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Dicentra Inc., University of British Columbia
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 16 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 8 participants assigned to Palmitoylethanolamide 8 participants assigned to Echinacea purpurea 8 participants assigned to Curcumin 8 participants assigned to N-Acetyl-L-cysteine
| Arm | Type | Receives |
|---|---|---|
| N-Acetyl-L-cysteine (NAC) | Active comparator | Dietary Supplement: N-Acetyl-L-cysteine (NAC)600 mg 1 capsule twice daily for 14 days |
| Echinacea purpurea | Active comparator | Dietary Supplement: Echinacea purpurea252 mg 1 capsule twice daily for 14 days |
| Curcumin | Active comparator | Dietary Supplement: Curcumin60 mg 3 capsules once daily for 14 days |
| Palmitoylethanolamide | Active comparator | Dietary Supplement: Palmitoylethanolamide400 mg 3 capsules once daily for 14 days |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects meeting all of the following criteria will be considered for admission to the study:
Key exclusion criteria (19 listed)
- Subjects meeting any of the following criteria will not be eligible for the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-Acetyl-L-cysteine (NAC)Also: NACHealth Canada Natural Product Number (NPN) 80056946 | Dietary supplement | N-Acetyl-L-cysteine (NAC) |
| Echinacea purpureaHealth Canada Natural Product Number (NPN) 80093896 | Dietary supplement | Echinacea purpurea |
| CurcuminHealth Canada Natural Product Number (NPN) 80043455 | Dietary supplement | Curcumin |
| PalmitoylethanolamideHealth Canada Natural Product Number (NPN) 80097472 | Dietary supplement | Palmitoylethanolamide |
Primary outcome
Change in participants T & B cell Diversity Index (D50) from day 0 to day 29
Time frame: 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gurinder Raj, MD principal investigator
dicentra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing N-Acetyl-L-cysteine (NAC), Echinacea purpurea and Curcumin in people with Immunity Disorders, run by Immunoflex Therapeutics Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in participants T & B cell Diversity Index (D50) from day 0 to day 29 (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.