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

NCT05242718 | Completed

• 1 other identifier: IMFX.CT1.002
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immunity Disorders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

N-Acetyl-L-cysteine (NAC)

ACTIVE COMPARATOR

600 mg 1 capsule twice daily for 14 days

Dietary Supplement: N-Acetyl-L-cysteine (NAC)

Echinacea purpurea

ACTIVE COMPARATOR

252 mg 1 capsule twice daily for 14 days

Dietary Supplement: Echinacea purpurea

Curcumin

ACTIVE COMPARATOR

60 mg 3 capsules once daily for 14 days

Dietary Supplement: Curcumin

Palmitoylethanolamide

ACTIVE COMPARATOR

400 mg 3 capsules once daily for 14 days

Dietary Supplement: Palmitoylethanolamide

Interventions

N-Acetyl-L-cysteine (NAC) DIETARY_SUPPLEMENT

Health Canada Natural Product Number (NPN) 80056946

Also known as: NAC

N-Acetyl-L-cysteine (NAC)

Echinacea purpurea DIETARY_SUPPLEMENT

Health Canada Natural Product Number (NPN) 80093896

Echinacea purpurea

Curcumin DIETARY_SUPPLEMENT

Health Canada Natural Product Number (NPN) 80043455

Curcumin

Palmitoylethanolamide DIETARY_SUPPLEMENT

Health Canada Natural Product Number (NPN) 80097472

Palmitoylethanolamide

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Immunoflex Therapeutics Inc.: lead
• Dicentra Inc.: collaborator
• University of British Columbia: collaborator

Study Sites (1)

Dicentra

Toronto, Ontario, M5S2B7, Canada

Location

MeSH Terms

Conditions

Immune System Diseases

Interventions

Acetylcysteine; Echinacea extract; Curcumin; palmidrol

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Gurinder Raj, MD

  dicentra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 8 participants assigned to Palmitoylethanolamide 8 participants assigned to Echinacea purpurea 8 participants assigned to Curcumin 8 participants assigned to N-Acetyl-L-cysteine

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 16, 2022
• Study Start: January 10, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 20, 2021
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

CA (1)