Clinical trial NCT05414838: Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements
Official title: Pilot Assessment of the Safety of a Combination of Curcumin, Omega-3, and Vitamin D Supplements (PASCOD) in Healthy Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Curcumin, Omega-3 and Vitamin-D (COD) are commonly used dietary supplements, which are licensed natural health products in Canada. The investigators are interested to see what effects (good or bad) these supplements taken in combination, might have on a person and the potential impact of these supplements, in combination, on inflammation and the immune system, in the body. This is because the investigators study Rheumatoid Arthritis (RA), an autoimmune disease that affects the joints of the body, causing joint pain and swelling.

The investigators want to first evaluate the tolerability and potential negative effects of these three supplements in combination, also known as "side-effects" in healthy persons. This pilot study will also help us determine the length of time research participants need for their research visits for future clinical trials.

The investigators also want to explore the utility and validity of two different 24-hour food recall methods (ASA24-Canada-2018 and Keenoa food diary) and the dietary inflammatory index (DII) using both recall methods. The DII is a score calculated from dietary data, to establish the inflammatory potential of an individual's diet.

This research pilot study aims to enroll 50 persons. The investigators want to identify common side effects of the supplements when all three are taken together, as well as any other potential side-effects that might occur that are not common. Based on the scientific research, persons who have taken these supplements individually (e.g., Vitamin D alone or Omega-3 alone), show that serious side effects are unlikely and if they do occur are mild. Pure curcumin, like that being administered in this study, containing no fillers, has not shown to have adverse effects and is well tolerated. However, no scientific studies have been done using all three of these nutritional supplements together, in humans.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give free informed consent and written consent in English, for participation in the trial
* Participant will provide contact information that includes telephone, email address and mailing address
* Age between 18 and 49 years old
* BMI range between 18.5 - 34.9 (kg/m2)
* Female participants of child-bearing potential must be willing to ensure that they use effective contraception during the trial
* Participant has clinically acceptable laboratory results including routine hematology (CBC) and biochemistry (electrolytes, creatinine, ALT, ALP, GGT, AST, Glucose)
* In the Investigator's opinion, is able and willing to comply with all trial requirements
* Participant is an employee or student at the Health Sciences Centre or Bannatyne Campus, by self-report
* Participants currently taking vitamin D and/or omega-3 supplements are willing to stop taking their own supplements prior to the start of this trial.
* Participant has received two-doses of a COVID-19 vaccine, with the second dose occurring no less than 4 weeks before Visit 1

Exclusion Criteria:

* Any history of clinically important and poorly controlled autoimmune disorders, endocrine disorders, cardiovascular disease, pulmonary, biliary or GI disorders, or any history of cancer requiring chemotherapy or radiation within the last 1 year
* Current use of warfarin or similar anticoagulant medication (at the discretion of the P.I.)
* Stomach ulcers (e.g., active peptic ulcer disease within the last 6 weeks) or poorly controlled gastric esophageal reflux disease (GERD)
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
* Female of childbearing potential who is unwilling to ensure effective contraception during the trial
* Scheduled elective surgery or other procedures requiring general anesthesia during the trial
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Concurrent commitment to enroll in another clinical trial
* Regular daily consumption of a Curcumin containing product within the last three months
* Self-report of allergic reaction to fish
* Self-reported body weight change of greater than 3.5 kg within the past 3 months, unexplained by medical history
* Participants who indicate that they will not consume the treatments on a daily basis
* Recent history (within 12 months of screening) or current consumption of \> 14 drinks per week, (1 drink = 12oz of beer, 5oz of wine or 1.5oz distilled spirits)
* Participants who report they have had viral or bacterial infection in the last 4 weeks (e.g.COVID-19, the flu, a cold, stomach flu, bladder infection, strep throat), and are not fully recovered
* Participants who have been vaccinated in the last 4 weeks and in the opinion of the Investigator may influence the result of the trial.

Primary outcomes:
measure: Self-reported Side Effects due to Supplements
timeFrame: 4 weeks
Secondary outcomes:
measure: Supplementation adherence
timeFrame: Day 28
Other outcomes:
measure: Alanine transaminase (ALT)
timeFrame: Baseline, Day 28
measure: Aspartate Aminotransferase (AST)
timeFrame: Baseline, Day 28
measure: Alkaline Phosphatase (ALK)
timeFrame: Baseline, Day 28
measure: Total Bilirubin
timeFrame: Baseline, Day 28
measure: Direct Bilirubin
timeFrame: Baseline, Day 28
measure: Urea
timeFrame: Baseline, Day 28
measure: Glucose
timeFrame: Baseline, Day 28
measure: Total Cholesterol
timeFrame: Baseline, Day 28
measure: Low-density lipoprotein (LDL)
timeFrame: Baseline, Day 28
measure: High-density lipoprotein (HDL)
timeFrame: Baseline, Day 28
measure: Triglycerides
timeFrame: Baseline, Day 28
measure: Sodium
timeFrame: Baseline, Day 28
measure: Potassium
timeFrame: Baseline, Day 28
measure: Chloride
timeFrame: Baseline, Day 28
measure: Calcium
timeFrame: Baseline, Day 28
measure: Bicarbonate
timeFrame: Baseline, Day 28
measure: Magnesium
timeFrame: Baseline, Day 28
measure: Albumin
timeFrame: Baseline, Day 28
measure: Phosphate
timeFrame: Baseline, Day 28
measure: Creatinine
timeFrame: Baseline, Day 28
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, Day 28
measure: White blood cells (WBC)
timeFrame: Baseline, Day 28
measure: Hemoglobin
timeFrame: Baseline, Day 28
measure: Platelets
timeFrame: Baseline, Day 28
measure: Mean platelet volume (MVP)
timeFrame: Baseline, Day 28
measure: Body weight
timeFrame: Baseline, Day 28
measure: Waist circumference
timeFrame: Baseline, Day 28
measure: Systolic Blood Pressure
timeFrame: Baseline, Day 28
measure: Diastolic Blood Pressure
timeFrame: Baseline, Day 28
measure: Hand Grip Strength
timeFrame: Baseline, Day 28
measure: Tender and Swollen Joint Count (TSJC)
timeFrame: Baseline, Day 28
measure: Physician Global Assessment of Disease Activity
timeFrame: Baseline, Day 28
measure: Routine Assessment of Patient Index Data 3 (RAPID 3)
timeFrame: Baseline, Day 28
measure: Simple Disease Activity Index (SDAI)
timeFrame: Baseline, Day 28
measure: Clinical Disease Activity Index (CDAI)
timeFrame: Baseline, Day 28
measure: Disease Activity Score-28- C-Reactive Protein (DAS28-CRP)
timeFrame: Baseline, Day 28
measure: Dietary Inflammatory Index
timeFrame: Baseline, Day 28
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Liam O'Neil, MD
role: PRINCIPAL_INVESTIGATOR
References: