Clinical trial NCT04033809: Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients
Official title: Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Fiber
Multigrain
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease Activity Score-28 (DAS-28)
timeFrame: Baseline and 12 weeks
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI)
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Blood glucose level
timeFrame: Baseline and 12 weeks
measure: Glycated hemoglobin (HbA1c)
timeFrame: Baseline and 12 weeks
measure: White blood cell (WBC) count
timeFrame: Baseline and 12 weeks
measure: Red blood cell (RBC) count
timeFrame: Baseline and 12 weeks
measure: Hemoglobin (Hb)
timeFrame: Baseline and 12 weeks
measure: Hematocrit (Hct)
timeFrame: Baseline and 12 weeks
measure: Mean corpuscular volume (MCV)
timeFrame: Baseline and 12 weeks
measure: Mean corpuscular hemoglobin (MCH)
timeFrame: Baseline and 12 weeks
measure: Platelet (PLT) count
timeFrame: Baseline and 12 weeks
measure: Total cholesterol
timeFrame: Baseline and 12 weeks
measure: Low density lipoprotein (LDL)-cholesterol
timeFrame: Baseline and 12 weeks
measure: High density lipoprotein (HDL)-cholesterol
timeFrame: Baseline and 12 weeks
measure: Triglyceride (Tg)
timeFrame: Baseline and 12 weeks
measure: Sodium level
timeFrame: Baseline and 12 weeks
measure: Potassium level
timeFrame: Baseline and 12 weeks
measure: Chloride level
timeFrame: Baseline and 12 weeks
measure: Blood urea nitrogen (BUN) level
timeFrame: Baseline and 12 weeks
measure: Serum creatinine level
timeFrame: Baseline and 12 weeks
measure: Calcium level
timeFrame: Baseline and 12 weeks
measure: Uric acid level
timeFrame: Baseline and 12 weeks
measure: Phosphorus level
timeFrame: Baseline and 12 weeks
measure: Albumin
timeFrame: Baseline and 12 weeks
measure: Total protein
timeFrame: Baseline and 12 weeks
measure: Total bilirubin
timeFrame: Baseline and 12 weeks
measure: Alkaline phosphatase (ALP)
timeFrame: Baseline and 12 weeks
measure: Alanine transaminase (ALT)
timeFrame: Baseline and 12 weeks
measure: Aspartate transaminase (AST)
timeFrame: Baseline and 12 weeks
measure: Serum interleukin-6 (IL-6)
timeFrame: Baseline and 12 weeks
measure: Serum interleukin 1β (IL-1β)
timeFrame: Baseline and 12 weeks
measure: Tumor necrosis factor-alpha (TNF-α)
timeFrame: Baseline and 12 weeks
measure: High sensitivity-C-Reactive Protein (hs-CRP)
timeFrame: Baseline and 12 weeks
measure: Serum matrix metalloproteinase-3 (MMP-3)
timeFrame: Baseline and 12 weeks
measure: Body mass index (BMI)
timeFrame: 12 weeks
measure: Waist hip ratio
timeFrame: 12 weeks
measure: Body fat
timeFrame: Baseline and 12 weeks
measure: Fat mass
timeFrame: Baseline and 12 weeks
measure: Fat free mass
timeFrame: Baseline and 12 weeks
measure: Total body water
timeFrame: Baseline and 12 weeks
measure: Estimated average required energy
timeFrame: Baseline and 12 weeks
measure: Tolerability assessment
timeFrame: At 4 weeks, 8 weeks and 12 weeks
measure: Compliance assessment
timeFrame: At 4 weeks, 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Lai Kuan Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: