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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin, Omega-3 and Vitamin-D (COD) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Curcumin, Omega-3 and Vitamin-D (COD) | Dietary Supplement | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Side Effects due to Supplements | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Supplementation adherence | 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Alanine transaminase (ALT) | ALT is measured in U/L | Baseline, Day 28 |
| Aspartate Aminotransferase (AST) | AST is measured in U/L | Baseline, Day 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liam O'Neil, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
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| ID | Term |
|---|---|
| D003474 | Curcumin |
| D004281 | Docosahexaenoic Acids |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| Alkaline Phosphatase (ALK) | AST is measured in U/L | Baseline, Day 28 |
| Total Bilirubin | Total blood bilirubin is measured in μmol/L | Baseline, Day 28 |
| Direct Bilirubin | Direct bilirubin is measured in μmol/L | Baseline, Day 28 |
| Urea | The total blood urea concentration in mmol/L | Baseline, Day 28 |
| Glucose | Total fasted blood glucose concentration in mmol/L | Baseline, Day 28 |
| Total Cholesterol | Total cholesterol measured in mmol/L | Baseline, Day 28 |
| Low-density lipoprotein (LDL) | LDL measured in mmol/L | Baseline, Day 28 |
| High-density lipoprotein (HDL) | HDL measured in mmol/L | Baseline, Day 28 |
| Triglycerides | Non-fasted triglycerides measured in mmol/L | Baseline, Day 28 |
| Sodium | Total blood sodium concentration in mmol/L | Baseline, Day 28 |
| Potassium | Total blood potassium concentration in mmol/L | Baseline, Day 28 |
| Chloride | Total blood chloride concentration in mmol/L | Baseline, Day 28 |
| Calcium | Total blood calcium concentration in mmol/L | Baseline, Day 28 |
| Bicarbonate | Bicarbonate measured in mmol/L | Baseline, Day 28 |
| Magnesium | Magnesium measured in mmol/L | Baseline, Day 28 |
| Albumin | Total blood albumin concentration in g/L | Baseline, Day 28 |
| Phosphate | Total blood phosphate concentration in mmol/L | Baseline, Day 28 |
| Creatinine | Total blood creatinine concentration in μmol/L | Baseline, Day 28 |
| C-Reactive Protein (CRP) | CRP measured in mg/L | Baseline, Day 28 |
| White blood cells (WBC) | WBC measured in x10^9/L | Baseline, Day 28 |
| Hemoglobin | Hemoglobin measured in g/L | Baseline, Day 28 |
| Platelets | Platelets measured in x10^9/L | Baseline, Day 28 |
| Mean platelet volume (MVP) | MVP measured in fL | Baseline, Day 28 |
| Body weight | Body weight will be measured in kg | Baseline, Day 28 |
| Waist circumference | Waist circumference will be measured in cm | Baseline, Day 28 |
| Systolic Blood Pressure | Systolic blood pressure in mmHg | Baseline, Day 28 |
| Diastolic Blood Pressure | Diastolic blood pressure in mmHg | Baseline, Day 28 |
| Hand Grip Strength | Measured using a dynamometer in kg, taken in triplicate | Baseline, Day 28 |
| Tender and Swollen Joint Count (TSJC) | 44 joints assessed by a rheumatologist | Baseline, Day 28 |
| Physician Global Assessment of Disease Activity | Severity measured on a scale from 0 to 10 | Baseline, Day 28 |
| Routine Assessment of Patient Index Data 3 (RAPID 3) | Disease activity index calculated from a short and questionnaire | Baseline, Day 28 |
| Simple Disease Activity Index (SDAI) | A score that determines severity of rheumatoid arthritis using clinical and laboratory data | Baseline, Day 28 |
| Clinical Disease Activity Index (CDAI) | A score that determines severity of rheumatoid arthritis using only clinical data | Baseline, Day 28 |
| Disease Activity Score-28- C-Reactive Protein (DAS28-CRP) | A score that describes severity of rheumatoid arthritis using clinical data and CRP | Baseline, Day 28 |
| Dietary Inflammatory Index | A score calculated from dietary data, to establish the inflammatory potential of an individual's diet. | Baseline, Day 28 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |