Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

NCT04033809 | Completed

• 1 other identifier: USM/JEPeM/19010081
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Fiber; Multigrain

Outcome Measures

Primary Outcomes (2)

• 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)

  Baseline and 12 weeks

• 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.

  Baseline and 12 weeks

Secondary Outcomes (41)

• Blood glucose level

  Baseline and 12 weeks

• Glycated hemoglobin (HbA1c)

  Baseline and 12 weeks

• White blood cell (WBC) count

  Baseline and 12 weeks

• Red blood cell (RBC) count

  Baseline and 12 weeks

• Hemoglobin (Hb)

  Baseline and 12 weeks

Study Arms (2)

Multigrain powder (S)

ACTIVE COMPARATOR

Oral high fiber multigrain supplements

Dietary Supplement: Multigrain powder (S)

Standard care (C)

NO INTERVENTION

Standard care without oral high fiber multigrain supplements

Interventions

Multigrain powder (S) DIETARY_SUPPLEMENT

A twice daily high fiber multigrain powder supplementation for 12 weeks

Multigrain powder (S)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

• Lai Kuan Lee, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 16, 2019
• First Posted: July 26, 2019
• Study Start: May 30, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)