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Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Multigrain powder (S)
Sponsored by
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Fiber, Multigrain

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universiti Sains Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Multigrain powder (S)

Standard care (C)

Arm Description

Oral high fiber multigrain supplements

Standard care without oral high fiber multigrain supplements

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Blood glucose level
Blood glucose is measured in mmol/L
Glycated hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) is measured in %
White blood cell (WBC) count
White blood cell (WBC) differential count is measured in x10^9/L
Red blood cell (RBC) count
Red blood cell (RBC) count is measured in x10^12/L
Hemoglobin (Hb)
Hemoglobin (Hb) is measured in g/dl
Hematocrit (Hct)
Hematocrit (Hct) is measured in %
Mean corpuscular volume (MCV)
Mean corpuscular volume (MCV) is measured in l/cell
Mean corpuscular hemoglobin (MCH)
Mean corpuscular hemoglobin (MCH) is measured in g/cell
Platelet (PLT) count
Platelet (PLT) count is measured in x10^9/L
Total cholesterol
Total cholesterol is measured in mmol/L
Low density lipoprotein (LDL)-cholesterol
Low density lipoprotein (LDL)-cholesterol is measured in mmol/L
High density lipoprotein (HDL)-cholesterol
High density lipoprotein (HDL)-cholesterol is measured in mmol/L
Triglyceride (Tg)
Triglyceride (Tg) is measured in mmol/L
Sodium level
Sodium level is measured in mmol/L
Potassium level
Potassium level is measured in mmol/L
Chloride level
Chloride level is measured in mmol/L
Blood urea nitrogen (BUN) level
Blood urea nitrogen (BUN) level is measured in mmol/L
Serum creatinine level
Serum creatinine level is measured in umol/L
Calcium level
Calcium level is measured in mmol/L
Uric acid level
Uric acid level is measured in umol/L
Phosphorus level
Phosphorus level is measured in mmol/L
Albumin
Albumin is measured in g/L
Total protein
Total protein is measured in g/L
Total bilirubin
Total bilirubin is measured in umol/L
Alkaline phosphatase (ALP)
Alkaline phosphatase (ALP) is measured in U/L
Alanine transaminase (ALT)
Alanine transaminase (ALT) is measured in U/L
Aspartate transaminase (AST)
Aspartate transaminase (AST) is measured in U/L
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
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
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
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
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
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
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.
Body fat
Body fat is measured in %
Fat mass
Fat mass is measured in %
Fat free mass
Fat free mass is measured in %
Total body water
Total body water is measured in L
Estimated average required energy
Estimated average required energy is measured in kcal
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.
Compliance assessment
Remaining sachet counting: The remaining sachet/unfinished sachet will be counted, and compliance will be reported as %.

Full Information

First Posted
July 16, 2019
Last Updated
May 8, 2023
Sponsor
Universiti Sains Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04033809
Brief Title
Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients
Official Title
Effectiveness of High Fiber Multigrain Supplementation Among the Rheumatoid Arthritis Patients: A Randomized, Open Label Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Fiber, Multigrain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multigrain powder (S)
Arm Type
Active Comparator
Arm Description
Oral high fiber multigrain supplements
Arm Title
Standard care (C)
Arm Type
No Intervention
Arm Description
Standard care without oral high fiber multigrain supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Multigrain powder (S)
Intervention Description
A twice daily high fiber multigrain powder supplementation for 12 weeks
Primary Outcome Measure Information:
Title
Disease Activity Score-28 (DAS-28)
Description
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)
Time Frame
Baseline and 12 weeks
Title
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
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.
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Blood glucose level
Description
Blood glucose is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Glycated hemoglobin (HbA1c)
Description
Glycated hemoglobin (HbA1c) is measured in %
Time Frame
Baseline and 12 weeks
Title
White blood cell (WBC) count
Description
White blood cell (WBC) differential count is measured in x10^9/L
Time Frame
Baseline and 12 weeks
Title
Red blood cell (RBC) count
Description
Red blood cell (RBC) count is measured in x10^12/L
Time Frame
Baseline and 12 weeks
Title
Hemoglobin (Hb)
Description
Hemoglobin (Hb) is measured in g/dl
Time Frame
Baseline and 12 weeks
Title
Hematocrit (Hct)
Description
Hematocrit (Hct) is measured in %
Time Frame
Baseline and 12 weeks
Title
Mean corpuscular volume (MCV)
Description
Mean corpuscular volume (MCV) is measured in l/cell
Time Frame
Baseline and 12 weeks
Title
Mean corpuscular hemoglobin (MCH)
Description
Mean corpuscular hemoglobin (MCH) is measured in g/cell
Time Frame
Baseline and 12 weeks
Title
Platelet (PLT) count
Description
Platelet (PLT) count is measured in x10^9/L
Time Frame
Baseline and 12 weeks
Title
Total cholesterol
Description
Total cholesterol is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Low density lipoprotein (LDL)-cholesterol
Description
Low density lipoprotein (LDL)-cholesterol is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
High density lipoprotein (HDL)-cholesterol
Description
High density lipoprotein (HDL)-cholesterol is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Triglyceride (Tg)
Description
Triglyceride (Tg) is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Sodium level
Description
Sodium level is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Potassium level
Description
Potassium level is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Chloride level
Description
Chloride level is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Blood urea nitrogen (BUN) level
Description
Blood urea nitrogen (BUN) level is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Serum creatinine level
Description
Serum creatinine level is measured in umol/L
Time Frame
Baseline and 12 weeks
Title
Calcium level
Description
Calcium level is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Uric acid level
Description
Uric acid level is measured in umol/L
Time Frame
Baseline and 12 weeks
Title
Phosphorus level
Description
Phosphorus level is measured in mmol/L
Time Frame
Baseline and 12 weeks
Title
Albumin
Description
Albumin is measured in g/L
Time Frame
Baseline and 12 weeks
Title
Total protein
Description
Total protein is measured in g/L
Time Frame
Baseline and 12 weeks
Title
Total bilirubin
Description
Total bilirubin is measured in umol/L
Time Frame
Baseline and 12 weeks
Title
Alkaline phosphatase (ALP)
Description
Alkaline phosphatase (ALP) is measured in U/L
Time Frame
Baseline and 12 weeks
Title
Alanine transaminase (ALT)
Description
Alanine transaminase (ALT) is measured in U/L
Time Frame
Baseline and 12 weeks
Title
Aspartate transaminase (AST)
Description
Aspartate transaminase (AST) is measured in U/L
Time Frame
Baseline and 12 weeks
Title
Serum interleukin-6 (IL-6)
Description
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
Time Frame
Baseline and 12 weeks
Title
Serum interleukin 1β (IL-1β)
Description
Interleukin 1β is among the most important proinflammatory cytokines in rheumatoid arthritis. Serum IL-1β is measured in pg/ml
Time Frame
Baseline and 12 weeks
Title
Tumor necrosis factor-alpha (TNF-α)
Description
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
Time Frame
Baseline and 12 weeks
Title
High sensitivity-C-Reactive Protein (hs-CRP)
Description
High sensitivity-C-Reactive Protein (hs-CRP) is a disease activity marker in rheumatoid arthritis. Serum hs-CRP is measured in pg/ml
Time Frame
Baseline and 12 weeks
Title
Serum matrix metalloproteinase-3 (MMP-3)
Description
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
Time Frame
Baseline and 12 weeks
Title
Body mass index (BMI)
Description
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
Time Frame
12 weeks
Title
Waist hip ratio
Description
Waist (in cm) and hip (in cm) circumferences will be measured to indicate obesity. This is calculated as waist measurement divided by hip measurement.
Time Frame
12 weeks
Title
Body fat
Description
Body fat is measured in %
Time Frame
Baseline and 12 weeks
Title
Fat mass
Description
Fat mass is measured in %
Time Frame
Baseline and 12 weeks
Title
Fat free mass
Description
Fat free mass is measured in %
Time Frame
Baseline and 12 weeks
Title
Total body water
Description
Total body water is measured in L
Time Frame
Baseline and 12 weeks
Title
Estimated average required energy
Description
Estimated average required energy is measured in kcal
Time Frame
Baseline and 12 weeks
Title
Tolerability assessment
Description
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.
Time Frame
At 4 weeks, 8 weeks and 12 weeks
Title
Compliance assessment
Description
Remaining sachet counting: The remaining sachet/unfinished sachet will be counted, and compliance will be reported as %.
Time Frame
At 4 weeks, 8 weeks and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lai Kuan Lee, PhD
Organizational Affiliation
Universiti Sains Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Sains Malaysia
City
Kubang Kerian
State/Province
Kelantan
ZIP/Postal Code
16150
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

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