Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Fiber, Multigrain
Brief summary
The objective of this study is to evaluate the effect of high fiber multigrain supplementation on the level of clinical disease severity measures, blood inflammatory molecules, and nutritional status changes in RA patients.
Detailed description
Rheumatoid Arthritis (RA) is a chronic inflammatory, autoimmune rheumatic disease, resulting in progressive joint inflammation and destruction. At present, there is no known cure for this disease. As a consequence of the potential side effects, many RA patients turn to other alternative remedies such as specialised diets and/or dietary supplements in a bid to relieve their symptoms. Therefore, the current study aims to examine the effectiveness of high fiber multigrain supplementation on the level of clinical disease severity measures, blood inflammatory molecules, together with the nutritional status changes in RA patients, as compare with conventional drug treatments.
Interventions
DIETARY_SUPPLEMENTMultigrain powder (S)
A twice daily high fiber multigrain powder supplementation for 12 weeks
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* RA patients according to the American College of Rheumatology (ACR) * Moderate (DAS 28 = 3.2 - 5.1) and severe (DAS 28 \> 5.1) RA manifestation * Chronological age: 21 years and above * Stable RA patients who are receiving NSAIDs, glucocorticoids/DMARDs (for example leflunomide, methotrexate, sulfasalazine and hydroxychloroquine) for at least 3 months prior to entering the study * Not taking antioxidant/antiinflammatory supplements (Example of antioxidant: vitamin C, vitamin E, grape seed extract, garlic capsule, ginkgo biloba) (Example of anti-inflammatory supplement: fish oil, curcumin extract, ginger extract, spirulina)
Exclusion criteria
* Having liver (chronic liver failure, cirrhosis, all types of hepatitis), kidney (chronic kidney disease, haemodialysis) or haematological (anaemia, thalassemia, haemophilia) disorders * Active gastric/duodenal ulcer * Psychiatric disease/mental retardation (bipolar disorder, depression, schizophrenia) * Cancer (all types), Diabetes Mellitus (Type I and II), uncontrolled hypertension (BP at 140/90 mmHg for the past 3 months), and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism). * Alcohol and drug abuse (self-mentioned or as recorded in the medical card) * Other autoimmune/inflammatory diseases (systemic lupus erythematosus, multiple sclerosis, gout, psoriasis, chronic inflammatory demyelinating polyneuropathy) * Pregnancy/lactation * Hormone replacement therapy (for at least 3 months prior to entering the study) * Herbal remedies (any parts from the plants such as flowers, rhizome, seeds, roots, leaves, fruits, stems) * Vegetarian patient (pure vegan) * Gluten intolerance * Participations from another supplementary program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score-28 (DAS-28) | Baseline and 12 weeks | The DAS-28 is a system developed and validated by the EULAR (European League Against Rheumatism) to measure the progress and improvement of Rheumatoid Arthritis. DAS-28 values range from 2.0 to 10.0, while higher values mean a higher disease activity. The complex mathematical calculation is calculated by incorporating the value of erythrocyte sedimentation rate (ESR) and Visual Analog Scale (VAS). ESR (mm/hr) determines the severity of inflammatory response and monitor the effect of treatment. VAS is an indicator for pain intensity and patient global health, and the following cut points have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm). DAS-28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.70 \* ln(ESR) + 0.014 \* GH The scale categorises RA manifestations as mild (DAS-28: \<3.2), moderate (DAS-28: 3.2-5.1) or severe (DAS-28: \>5.1) |
| Health Assessment Questionnaire-Disability Index (HAQ-DI) | Baseline and 12 weeks | The HAQ-DI is used to measure physical functionality. The HAQ-DI is usually analyzed by calculating scores. The single scales range from 0 (no difficulty) to 3 (unable to do). The total score ranges from 0-24, and higher score indicates severe disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood glucose level | Baseline and 12 weeks | Blood glucose is measured in mmol/L |
| Glycated hemoglobin (HbA1c) | Baseline and 12 weeks | Glycated hemoglobin (HbA1c) is measured in % |
| Hemoglobin (Hb) | Baseline and 12 weeks | Hemoglobin (Hb) is measured in g/dl |
| Hematocrit (Hct) | Baseline and 12 weeks | Hematocrit (Hct) is measured in % |
| Mean corpuscular volume (MCV) | Baseline and 12 weeks | Mean corpuscular volume (MCV) is measured in l/cell |
| Mean corpuscular hemoglobin (MCH) | Baseline and 12 weeks | Mean corpuscular hemoglobin (MCH) is measured in g/cell |
| Platelet (PLT) count | Baseline and 12 weeks | Platelet (PLT) count is measured in x10\^9/L |
| Total cholesterol | Baseline and 12 weeks | Total cholesterol is measured in mmol/L |
| Low density lipoprotein (LDL)-cholesterol | Baseline and 12 weeks | Low density lipoprotein (LDL)-cholesterol is measured in mmol/L |
| High density lipoprotein (HDL)-cholesterol | Baseline and 12 weeks | High density lipoprotein (HDL)-cholesterol is measured in mmol/L |
| Triglyceride (Tg) | Baseline and 12 weeks | Triglyceride (Tg) is measured in mmol/L |
| Sodium level | Baseline and 12 weeks | Sodium level is measured in mmol/L |
| Potassium level | Baseline and 12 weeks | Potassium level is measured in mmol/L |
| Chloride level | Baseline and 12 weeks | Chloride level is measured in mmol/L |
| Blood urea nitrogen (BUN) level | Baseline and 12 weeks | Blood urea nitrogen (BUN) level is measured in mmol/L |
| Serum creatinine level | Baseline and 12 weeks | Serum creatinine level is measured in umol/L |
| Calcium level | Baseline and 12 weeks | Calcium level is measured in mmol/L |
| Uric acid level | Baseline and 12 weeks | Uric acid level is measured in umol/L |
| Phosphorus level | Baseline and 12 weeks | Phosphorus level is measured in mmol/L |
| Albumin | Baseline and 12 weeks | Albumin is measured in g/L |
| Total protein | Baseline and 12 weeks | Total protein is measured in g/L |
| Total bilirubin | Baseline and 12 weeks | Total bilirubin is measured in umol/L |
| Alkaline phosphatase (ALP) | Baseline and 12 weeks | Alkaline phosphatase (ALP) is measured in U/L |
| Alanine transaminase (ALT) | Baseline and 12 weeks | Alanine transaminase (ALT) is measured in U/L |
| Aspartate transaminase (AST) | Baseline and 12 weeks | Aspartate transaminase (AST) is measured in U/L |
| Serum interleukin-6 (IL-6) | Baseline and 12 weeks | Interleukin-6 (IL-6) is a pleiotropic cytokine with a pivotal role in the pathophysiology of rheumatoid arthritis. The level correlates with the disease activity and joint destruction. Serum IL-6 is measured in pg/ml |
| Serum interleukin 1β (IL-1β) | Baseline and 12 weeks | Interleukin 1β is among the most important proinflammatory cytokines in rheumatoid arthritis. Serum IL-1β is measured in pg/ml |
| Tumor necrosis factor-alpha (TNF-α) | Baseline and 12 weeks | Tumor necrosis factor-alpha (TNF-α) is a proinflammatory cytokine that plays a pivotal role in regulating the inflammatory response in rheumatoid arthritis. Serum IL-1β is measured in pg/ml |
| High sensitivity-C-Reactive Protein (hs-CRP) | Baseline and 12 weeks | High sensitivity-C-Reactive Protein (hs-CRP) is a disease activity marker in rheumatoid arthritis. Serum hs-CRP is measured in pg/ml |
| Serum matrix metalloproteinase-3 (MMP-3) | Baseline and 12 weeks | MMP-3 is increased in rheumatoid arthritis, and has been proposed as a marker of joint damage and systemic inflammation. Serum MMP-3 is measured in ng/ml |
| Body mass index (BMI) | 12 weeks | Body weight (in kilograms) and standing height (in meters) will be measured to indicate nutritional status. The weight and height will be combined to report BMI in kg/m\^2 |
| Waist hip ratio | 12 weeks | Waist (in cm) and hip (in cm) circumferences will be measured to indicate obesity. This is calculated as waist measurement divided by hip measurement. |
| Body fat | Baseline and 12 weeks | Body fat is measured in % |
| Fat mass | Baseline and 12 weeks | Fat mass is measured in % |
| Fat free mass | Baseline and 12 weeks | Fat free mass is measured in % |
| White blood cell (WBC) count | Baseline and 12 weeks | White blood cell (WBC) differential count is measured in x10\^9/L |
| Estimated average required energy | Baseline and 12 weeks | Estimated average required energy is measured in kcal |
| Tolerability assessment | At 4 weeks, 8 weeks and 12 weeks | The participant's complaints of gastrointestinal discomfort upon supplement consumption such as heart burn, diarrhea, nausea, vomiting and headache will be recorded, and it will be reported as the frequency (n) of discomfort episodes. |
| Compliance assessment | At 4 weeks, 8 weeks and 12 weeks | Remaining sachet counting: The remaining sachet/unfinished sachet will be counted, and compliance will be reported as %. |
| Total body water | Baseline and 12 weeks | Total body water is measured in L |
| Red blood cell (RBC) count | Baseline and 12 weeks | Red blood cell (RBC) count is measured in x10\^12/L |
Countries
Malaysia
Outcome results
None listed