Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients
- Conditions
- Rheumatoid Arthritis
- Interventions
- Dietary Supplement: Multigrain powder (S)
- Registration Number
- NCT04033809
- Lead Sponsor
- Universiti Sains Malaysia
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multigrain powder (S) Multigrain powder (S) Oral high fiber multigrain supplements
- Primary Outcome Measures
Name Time Method 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.
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)
- Secondary Outcome Measures
Name Time Method Glycated hemoglobin (HbA1c) Baseline and 12 weeks Glycated hemoglobin (HbA1c) is measured in %
Hematocrit (Hct) Baseline and 12 weeks Hematocrit (Hct) is measured in %
Platelet (PLT) count Baseline and 12 weeks Platelet (PLT) count is measured in x10\^9/L
Triglyceride (Tg) Baseline and 12 weeks Triglyceride (Tg) is measured in mmol/L
Potassium level Baseline and 12 weeks Potassium level is measured in mmol/L
Total protein Baseline and 12 weeks Total protein is measured in g/L
Blood glucose level Baseline and 12 weeks Blood glucose is measured in mmol/L
Mean corpuscular volume (MCV) Baseline and 12 weeks Mean corpuscular volume (MCV) is measured in l/cell
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
Hemoglobin (Hb) Baseline and 12 weeks Hemoglobin (Hb) is measured in g/dl
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
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
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
Sodium level Baseline and 12 weeks Sodium level is measured in mmol/L
White blood cell (WBC) count Baseline and 12 weeks White blood cell (WBC) differential count is measured in x10\^9/L
Red blood cell (RBC) count Baseline and 12 weeks Red blood cell (RBC) count is measured in x10\^12/L
Mean corpuscular hemoglobin (MCH) Baseline and 12 weeks Mean corpuscular hemoglobin (MCH) is measured in g/cell
High density lipoprotein (HDL)-cholesterol Baseline and 12 weeks High density lipoprotein (HDL)-cholesterol is measured in mmol/L
Total bilirubin Baseline and 12 weeks Total bilirubin is measured in umol/L
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
Chloride level Baseline and 12 weeks Chloride 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
Alanine transaminase (ALT) Baseline and 12 weeks Alanine transaminase (ALT) is measured in U/L
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
Fat free mass Baseline and 12 weeks Fat free mass is measured in %
Blood urea nitrogen (BUN) level Baseline and 12 weeks Blood urea nitrogen (BUN) level is measured in mmol/L
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 %
Alkaline phosphatase (ALP) Baseline and 12 weeks Alkaline phosphatase (ALP) is measured in U/L
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
Fat mass Baseline and 12 weeks Fat mass is measured in %
Estimated average required energy Baseline and 12 weeks Estimated average required energy is measured in kcal
Total body water Baseline and 12 weeks Total body water is measured in L
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 %.
Trial Locations
- Locations (1)
Universiti Sains Malaysia
🇲🇾Kubang Kerian, Kelantan, Malaysia