Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Health Assessment Questionnaire-Disability Index (HAQ-DI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Health Assessment Questionnaire-Disability Index (HAQ-DI)
时间窗: 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)
时间窗: 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)
次要结局
- Total protein(Baseline and 12 weeks)
- Blood glucose level(Baseline and 12 weeks)
- Mean corpuscular volume (MCV)(Baseline and 12 weeks)
- Glycated hemoglobin (HbA1c)(Baseline and 12 weeks)
- Hematocrit (Hct)(Baseline and 12 weeks)
- Platelet (PLT) count(Baseline and 12 weeks)
- Triglyceride (Tg)(Baseline and 12 weeks)
- Potassium level(Baseline and 12 weeks)
- Aspartate transaminase (AST)(Baseline and 12 weeks)
- Hemoglobin (Hb)(Baseline and 12 weeks)
- Serum interleukin-6 (IL-6)(Baseline and 12 weeks)
- High sensitivity-C-Reactive Protein (hs-CRP)(Baseline and 12 weeks)
- Body mass index (BMI)(12 weeks)
- Total cholesterol(Baseline and 12 weeks)
- Low density lipoprotein (LDL)-cholesterol(Baseline and 12 weeks)
- Sodium level(Baseline and 12 weeks)
- White blood cell (WBC) count(Baseline and 12 weeks)
- Red blood cell (RBC) count(Baseline and 12 weeks)
- Mean corpuscular hemoglobin (MCH)(Baseline and 12 weeks)
- High density lipoprotein (HDL)-cholesterol(Baseline and 12 weeks)
- Total bilirubin(Baseline and 12 weeks)
- Serum matrix metalloproteinase-3 (MMP-3)(Baseline and 12 weeks)
- Chloride level(Baseline and 12 weeks)
- Serum creatinine level(Baseline and 12 weeks)
- Calcium level(Baseline and 12 weeks)
- Uric acid level(Baseline and 12 weeks)
- Phosphorus level(Baseline and 12 weeks)
- Albumin(Baseline and 12 weeks)
- Alanine transaminase (ALT)(Baseline and 12 weeks)
- Tumor necrosis factor-alpha (TNF-α)(Baseline and 12 weeks)
- Fat free mass(Baseline and 12 weeks)
- Blood urea nitrogen (BUN) level(Baseline and 12 weeks)
- Waist hip ratio(12 weeks)
- Body fat(Baseline and 12 weeks)
- Alkaline phosphatase (ALP)(Baseline and 12 weeks)
- Serum interleukin 1β (IL-1β)(Baseline and 12 weeks)
- Fat mass(Baseline and 12 weeks)
- Estimated average required energy(Baseline and 12 weeks)
- Total body water(Baseline and 12 weeks)
- Tolerability assessment(At 4 weeks, 8 weeks and 12 weeks)
- Compliance assessment(At 4 weeks, 8 weeks and 12 weeks)
研究者
Dr. Lee Lai Kuan
Principal Investigator
Universiti Sains Malaysia