Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 22 May 2023
• Main ID: NCT04033809
• Date of registration: 16/07/2019
• Prospective Registration: No
• Primary sponsor: Universiti Sains Malaysia
• Public title: Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients
• Scientific title: Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial
• Date of first enrolment: May 30, 2019
• Target sample size: 54
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04033809
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Malaysia

Contacts

• Name: Lai Kuan Lee, PhD
• Affiliation: Universiti Sains Malaysia

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Dietary Supplement: Multigrain powder (S)

Primary Outcome(s)

Health Assessment Questionnaire-Disability Index (HAQ-DI) [Time Frame: Baseline and 12 weeks]

Disease Activity Score-28 (DAS-28) [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

Hemoglobin (Hb) [Time Frame: Baseline and 12 weeks]

Mean corpuscular hemoglobin (MCH) [Time Frame: Baseline and 12 weeks]

Serum matrix metalloproteinase-3 (MMP-3) [Time Frame: Baseline and 12 weeks]

Total bilirubin [Time Frame: Baseline and 12 weeks]

Total protein [Time Frame: Baseline and 12 weeks]

Waist hip ratio [Time Frame: 12 weeks]

Albumin [Time Frame: Baseline and 12 weeks]

Blood urea nitrogen (BUN) level [Time Frame: Baseline and 12 weeks]

Body fat [Time Frame: Baseline and 12 weeks]

Glycated hemoglobin (HbA1c) [Time Frame: Baseline and 12 weeks]

High sensitivity-C-Reactive Protein (hs-CRP) [Time Frame: Baseline and 12 weeks]

Low density lipoprotein (LDL)-cholesterol [Time Frame: Baseline and 12 weeks]

Potassium level [Time Frame: Baseline and 12 weeks]

Tolerability assessment [Time Frame: At 4 weeks, 8 weeks and 12 weeks]

Total cholesterol [Time Frame: Baseline and 12 weeks]

Chloride level [Time Frame: Baseline and 12 weeks]

Hematocrit (Hct) [Time Frame: Baseline and 12 weeks]

High density lipoprotein (HDL)-cholesterol [Time Frame: Baseline and 12 weeks]

Serum interleukin 1ß (IL-1ß) [Time Frame: Baseline and 12 weeks]

Tumor necrosis factor-alpha (TNF-a) [Time Frame: Baseline and 12 weeks]

Uric acid level [Time Frame: Baseline and 12 weeks]

Alkaline phosphatase (ALP) [Time Frame: Baseline and 12 weeks]

Estimated average required energy [Time Frame: Baseline and 12 weeks]

Fat mass [Time Frame: Baseline and 12 weeks]

Fat free mass [Time Frame: Baseline and 12 weeks]

Total body water [Time Frame: Baseline and 12 weeks]

White blood cell (WBC) count [Time Frame: Baseline and 12 weeks]

Calcium level [Time Frame: Baseline and 12 weeks]

Compliance assessment [Time Frame: At 4 weeks, 8 weeks and 12 weeks]

Phosphorus level [Time Frame: Baseline and 12 weeks]

Platelet (PLT) count [Time Frame: Baseline and 12 weeks]

Alanine transaminase (ALT) [Time Frame: Baseline and 12 weeks]

Aspartate transaminase (AST) [Time Frame: Baseline and 12 weeks]

Blood glucose level [Time Frame: Baseline and 12 weeks]

Body mass index (BMI) [Time Frame: 12 weeks]

Mean corpuscular volume (MCV) [Time Frame: Baseline and 12 weeks]

Red blood cell (RBC) count [Time Frame: Baseline and 12 weeks]

Serum creatinine level [Time Frame: Baseline and 12 weeks]

Serum interleukin-6 (IL-6) [Time Frame: Baseline and 12 weeks]

Triglyceride (Tg) [Time Frame: Baseline and 12 weeks]

Sodium level [Time Frame: Baseline and 12 weeks]

Secondary ID(s)

USM/JEPeM/19010081

Source(s) of Monetary Support

Please refer to primary and secondary sponsors