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Rheumatoid ArthritisNCT04033809

Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

A study testing Multigrain powder (S) in people with Rheumatoid Arthritis, run by Universiti Sains Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Multigrain powder (S)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteMalaysia
Study dates
30 May 2019to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150

Other trials in Malaysia

About this study

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

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.

Read the 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.

Being tested
Multigrain powder (S)
Keywords
Rheumatoid Arthritis, Fiber, Multigrain
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multigrain powder (S)Dietary supplement

    A twice daily high fiber multigrain powder supplementation for 12 weeks

Study groups in NCT04033809
Study groupRoleWhat they receive
Multigrain powder (S)Active comparatorOral high fiber multigrain supplements
Receives: Dietary Supplement: Multigrain powder (S)
Standard care (C)No interventionStandard care without oral high fiber multigrain supplements

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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)

    Measured: Baseline and 12 weeks

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

    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.

    Measured: Baseline and 12 weeks

Secondary outcomes (41)

  1. Blood glucose level

    Blood glucose is measured in mmol/L

    Measured: Baseline and 12 weeks

  2. Glycated hemoglobin (HbA1c)

    Glycated hemoglobin (HbA1c) is measured in %

    Measured: Baseline and 12 weeks

  3. White blood cell (WBC) count

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

    Measured: Baseline and 12 weeks

  4. Red blood cell (RBC) count

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

    Measured: Baseline and 12 weeks

  5. Hemoglobin (Hb)

    Hemoglobin (Hb) is measured in g/dl

    Measured: Baseline and 12 weeks

  6. Hematocrit (Hct)

    Hematocrit (Hct) is measured in %

    Measured: Baseline and 12 weeks

  7. Mean corpuscular volume (MCV)

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

    Measured: Baseline and 12 weeks

  8. Mean corpuscular hemoglobin (MCH)

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

    Measured: Baseline and 12 weeks

  9. Platelet (PLT) count

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

    Measured: Baseline and 12 weeks

  10. Total cholesterol

    Total cholesterol is measured in mmol/L

    Measured: Baseline and 12 weeks

  11. Low density lipoprotein (LDL)-cholesterol

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

    Measured: Baseline and 12 weeks

  12. High density lipoprotein (HDL)-cholesterol

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

    Measured: Baseline and 12 weeks

  13. Triglyceride (Tg)

    Triglyceride (Tg) is measured in mmol/L

    Measured: Baseline and 12 weeks

  14. Sodium level

    Sodium level is measured in mmol/L

    Measured: Baseline and 12 weeks

  15. Potassium level

    Potassium level is measured in mmol/L

    Measured: Baseline and 12 weeks

  16. Chloride level

    Chloride level is measured in mmol/L

    Measured: Baseline and 12 weeks

  17. Blood urea nitrogen (BUN) level

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

    Measured: Baseline and 12 weeks

  18. Serum creatinine level

    Serum creatinine level is measured in umol/L

    Measured: Baseline and 12 weeks

  19. Calcium level

    Calcium level is measured in mmol/L

    Measured: Baseline and 12 weeks

  20. Uric acid level

    Uric acid level is measured in umol/L

    Measured: Baseline and 12 weeks

  21. Phosphorus level

    Phosphorus level is measured in mmol/L

    Measured: Baseline and 12 weeks

  22. Albumin

    Albumin is measured in g/L

    Measured: Baseline and 12 weeks

  23. Total protein

    Total protein is measured in g/L

    Measured: Baseline and 12 weeks

  24. Total bilirubin

    Total bilirubin is measured in umol/L

    Measured: Baseline and 12 weeks

  25. Alkaline phosphatase (ALP)

    Alkaline phosphatase (ALP) is measured in U/L

    Measured: Baseline and 12 weeks

  26. Alanine transaminase (ALT)

    Alanine transaminase (ALT) is measured in U/L

    Measured: Baseline and 12 weeks

  27. Aspartate transaminase (AST)

    Aspartate transaminase (AST) is measured in U/L

    Measured: Baseline and 12 weeks

  28. Serum interleukin-6 (IL-6)

    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

    Measured: Baseline and 12 weeks

  29. Serum interleukin 1β (IL-1β)

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

    Measured: Baseline and 12 weeks

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

    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

    Measured: Baseline and 12 weeks

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

    High sensitivity-C-Reactive Protein (hs-CRP) is a disease activity marker in rheumatoid arthritis. Serum hs-CRP is measured in pg/ml

    Measured: Baseline and 12 weeks

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

    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

    Measured: Baseline and 12 weeks

  33. Body mass index (BMI)

    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

    Measured: 12 weeks

  34. Waist hip ratio

    Waist (in cm) and hip (in cm) circumferences will be measured to indicate obesity. This is calculated as waist measurement divided by hip measurement.

    Measured: 12 weeks

  35. Body fat

    Body fat is measured in %

    Measured: Baseline and 12 weeks

  36. Fat mass

    Fat mass is measured in %

    Measured: Baseline and 12 weeks

  37. Fat free mass

    Fat free mass is measured in %

    Measured: Baseline and 12 weeks

  38. Total body water

    Total body water is measured in L

    Measured: Baseline and 12 weeks

  39. Estimated average required energy

    Estimated average required energy is measured in kcal

    Measured: Baseline and 12 weeks

  40. Tolerability assessment

    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.

    Measured: At 4 weeks, 8 weeks and 12 weeks

  41. Compliance assessment

    Remaining sachet counting: The remaining sachet/unfinished sachet will be counted, and compliance will be reported as %.

    Measured: At 4 weeks, 8 weeks and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2019
  2. Study start30 May 2019
  3. Primary completion30 Sep 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04033809
Sponsor's protocol ID
USM/JEPeM/19010081
Status last verified
May 2023
First submitted
16 Jul 2019
Last updated
10 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multigrain powder (S) in people with Rheumatoid Arthritis, run by Universiti Sains Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Activity Score-28 (DAS-28) (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04033809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

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