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Completed

NCT Number: NCT04033809

Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multigrain powder (S)

Dietary Supplement

A twice daily high fiber multigrain powder supplementation for 12 weeks

Primary outcomes

  1. Disease Activity Score-28 (DAS-28)

    Time frame: 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)

  2. Health Assessment Questionnaire-Disability Index (HAQ-DI)

    Time frame: 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 outcomes

  1. Blood glucose level

    Time frame: Baseline and 12 weeks

    Blood glucose is measured in mmol/L

  2. Glycated hemoglobin (HbA1c)

    Time frame: Baseline and 12 weeks

    Glycated hemoglobin (HbA1c) is measured in %

  3. White blood cell (WBC) count

    Time frame: Baseline and 12 weeks

    White blood cell (WBC) differential count is measured in x10^9/L

  4. Red blood cell (RBC) count

    Time frame: Baseline and 12 weeks

    Red blood cell (RBC) count is measured in x10^12/L

  5. Hemoglobin (Hb)

    Time frame: Baseline and 12 weeks

    Hemoglobin (Hb) is measured in g/dl

  6. Hematocrit (Hct)

    Time frame: Baseline and 12 weeks

    Hematocrit (Hct) is measured in %

  7. Mean corpuscular volume (MCV)

    Time frame: Baseline and 12 weeks

    Mean corpuscular volume (MCV) is measured in l/cell

  8. Mean corpuscular hemoglobin (MCH)

    Time frame: Baseline and 12 weeks

    Mean corpuscular hemoglobin (MCH) is measured in g/cell

  9. Platelet (PLT) count

    Time frame: Baseline and 12 weeks

    Platelet (PLT) count is measured in x10^9/L

  10. Total cholesterol

    Time frame: Baseline and 12 weeks

    Total cholesterol is measured in mmol/L

  11. Low density lipoprotein (LDL)-cholesterol

    Time frame: Baseline and 12 weeks

    Low density lipoprotein (LDL)-cholesterol is measured in mmol/L

  12. High density lipoprotein (HDL)-cholesterol

    Time frame: Baseline and 12 weeks

    High density lipoprotein (HDL)-cholesterol is measured in mmol/L

  13. Triglyceride (Tg)

    Time frame: Baseline and 12 weeks

    Triglyceride (Tg) is measured in mmol/L

  14. Sodium level

    Time frame: Baseline and 12 weeks

    Sodium level is measured in mmol/L

  15. Potassium level

    Time frame: Baseline and 12 weeks

    Potassium level is measured in mmol/L

  16. Chloride level

    Time frame: Baseline and 12 weeks

    Chloride level is measured in mmol/L

  17. Blood urea nitrogen (BUN) level

    Time frame: Baseline and 12 weeks

    Blood urea nitrogen (BUN) level is measured in mmol/L

  18. Serum creatinine level

    Time frame: Baseline and 12 weeks

    Serum creatinine level is measured in umol/L

  19. Calcium level

    Time frame: Baseline and 12 weeks

    Calcium level is measured in mmol/L

  20. Uric acid level

    Time frame: Baseline and 12 weeks

    Uric acid level is measured in umol/L

  21. Phosphorus level

    Time frame: Baseline and 12 weeks

    Phosphorus level is measured in mmol/L

  22. Albumin

    Time frame: Baseline and 12 weeks

    Albumin is measured in g/L

  23. Total protein

    Time frame: Baseline and 12 weeks

    Total protein is measured in g/L

  24. Total bilirubin

    Time frame: Baseline and 12 weeks

    Total bilirubin is measured in umol/L

  25. Alkaline phosphatase (ALP)

    Time frame: Baseline and 12 weeks

    Alkaline phosphatase (ALP) is measured in U/L

  26. Alanine transaminase (ALT)

    Time frame: Baseline and 12 weeks

    Alanine transaminase (ALT) is measured in U/L

  27. Aspartate transaminase (AST)

    Time frame: Baseline and 12 weeks

    Aspartate transaminase (AST) is measured in U/L

  28. Serum interleukin-6 (IL-6)

    Time frame: 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

  29. Serum interleukin 1β (IL-1β)

    Time frame: Baseline and 12 weeks

    Interleukin 1β is among the most important proinflammatory cytokines in rheumatoid arthritis. Serum IL-1β is measured in pg/ml

  30. Tumor necrosis factor-alpha (TNF-α)

    Time frame: 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

  31. High sensitivity-C-Reactive Protein (hs-CRP)

    Time frame: 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

  32. Serum matrix metalloproteinase-3 (MMP-3)

    Time frame: 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

  33. Body mass index (BMI)

    Time frame: 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

  34. Waist hip ratio

    Time frame: 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.

  35. Body fat

    Time frame: Baseline and 12 weeks

    Body fat is measured in %

  36. Fat mass

    Time frame: Baseline and 12 weeks

    Fat mass is measured in %

  37. Fat free mass

    Time frame: Baseline and 12 weeks

    Fat free mass is measured in %

  38. Total body water

    Time frame: Baseline and 12 weeks

    Total body water is measured in L

  39. Estimated average required energy

    Time frame: Baseline and 12 weeks

    Estimated average required energy is measured in kcal

  40. Tolerability assessment

    Time frame: 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.

  41. Compliance assessment

    Time frame: 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 %.

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2019
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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