Healthy Participants
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCurcumin, Omega-3 and Vitamin-D (COD)
Acumin™ Turmeric Complex (Dr. D's Ultra BioTurmeric) 500 mg daily (NPN 80087842) Omega-3 supplements (combination of DHA and EPA) 900 mg daily (NPN 80019234) Vitamin D3 supplements 2500 IU daily (NPN 80108995)
Sponsors
University of Manitoba
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Side Effects due to Supplements | 4 weeks | Participants will fill out a weekly monitoring survey to report side effects and health issues they may have had over the past week while taking the COD supplements. Participants will fill out a short survey weekly using a 0-3 scale of severity for a variety of gastrointestinal and health symptoms to analyze total side effects over the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Supplementation adherence | Day 28 | Medication adherence (\>75% pills consumed) Non-adherence (\<75% of the capsules consumed) Medication packs will be returned on Day 28 (+/- 2 days) of the trial. Remaining capsules will be counted and deemed to have been missed. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Alkaline Phosphatase (ALK) | Baseline, Day 28 | AST is measured in U/L |
| Total Bilirubin | Baseline, Day 28 | Total blood bilirubin is measured in μmol/L |
| Direct Bilirubin | Baseline, Day 28 | Direct bilirubin is measured in μmol/L |
| Urea | Baseline, Day 28 | The total blood urea concentration in mmol/L |
| Glucose | Baseline, Day 28 | Total fasted blood glucose concentration in mmol/L |
| Total Cholesterol | Baseline, Day 28 | Total cholesterol measured in mmol/L |
| Low-density lipoprotein (LDL) | Baseline, Day 28 | LDL measured in mmol/L |
| High-density lipoprotein (HDL) | Baseline, Day 28 | HDL measured in mmol/L |
| Triglycerides | Baseline, Day 28 | Non-fasted triglycerides measured in mmol/L |
| Sodium | Baseline, Day 28 | Total blood sodium concentration in mmol/L |
| Potassium | Baseline, Day 28 | Total blood potassium concentration in mmol/L |
| Chloride | Baseline, Day 28 | Total blood chloride concentration in mmol/L |
| Calcium | Baseline, Day 28 | Total blood calcium concentration in mmol/L |
| Bicarbonate | Baseline, Day 28 | Bicarbonate measured in mmol/L |
| Magnesium | Baseline, Day 28 | Magnesium measured in mmol/L |
| Albumin | Baseline, Day 28 | Total blood albumin concentration in g/L |
| Phosphate | Baseline, Day 28 | Total blood phosphate concentration in mmol/L |
| Alanine transaminase (ALT) | Baseline, Day 28 | ALT is measured in U/L |
| C-Reactive Protein (CRP) | Baseline, Day 28 | CRP measured in mg/L |
| White blood cells (WBC) | Baseline, Day 28 | WBC measured in x10\^9/L |
| Hemoglobin | Baseline, Day 28 | Hemoglobin measured in g/L |
| Platelets | Baseline, Day 28 | Platelets measured in x10\^9/L |
| Mean platelet volume (MVP) | Baseline, Day 28 | MVP measured in fL |
| Body weight | Baseline, Day 28 | Body weight will be measured in kg |
| Waist circumference | Baseline, Day 28 | Waist circumference will be measured in cm |
| Systolic Blood Pressure | Baseline, Day 28 | Systolic blood pressure in mmHg |
| Diastolic Blood Pressure | Baseline, Day 28 | Diastolic blood pressure in mmHg |
| Hand Grip Strength | Baseline, Day 28 | Measured using a dynamometer in kg, taken in triplicate |
| Tender and Swollen Joint Count (TSJC) | Baseline, Day 28 | 44 joints assessed by a rheumatologist |
| Physician Global Assessment of Disease Activity | Baseline, Day 28 | Severity measured on a scale from 0 to 10 |
| Routine Assessment of Patient Index Data 3 (RAPID 3) | Baseline, Day 28 | Disease activity index calculated from a short and questionnaire |
| Simple Disease Activity Index (SDAI) | Baseline, Day 28 | A score that determines severity of rheumatoid arthritis using clinical and laboratory data |
| Clinical Disease Activity Index (CDAI) | Baseline, Day 28 | A score that determines severity of rheumatoid arthritis using only clinical data |
| Disease Activity Score-28- C-Reactive Protein (DAS28-CRP) | Baseline, Day 28 | A score that describes severity of rheumatoid arthritis using clinical data and CRP |
| Dietary Inflammatory Index | Baseline, Day 28 | A score calculated from dietary data, to establish the inflammatory potential of an individual's diet. |
| Creatinine | Baseline, Day 28 | Total blood creatinine concentration in μmol/L |
| Aspartate Aminotransferase (AST) | Baseline, Day 28 | AST is measured in U/L |
Countries
Canada
Outcome results
None listed