Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

May 8, 2023 updated by: Dr. Lee Lai Kuan, Universiti Sains Malaysia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Multigrain powder (S)
Oral high fiber multigrain supplements
Dietary supplement: Multigrain powder (S)
A twice daily high fiber multigrain powder supplementation for 12 weeks
No Intervention: Standard care (C)
Standard care without oral high fiber multigrain supplements

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline and 12 weeks
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.
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood glucose level
Time Frame: Baseline and 12 weeks
Blood glucose is measured in mmol/L
Baseline and 12 weeks
Glycated hemoglobin (HbA1c)
Time Frame: Baseline and 12 weeks
Glycated hemoglobin (HbA1c) is measured in %
Baseline and 12 weeks
White blood cell (WBC) count
Time Frame: Baseline and 12 weeks
White blood cell (WBC) differential count is measured in x10^9/L
Baseline and 12 weeks
Red blood cell (RBC) count
Time Frame: Baseline and 12 weeks
Red blood cell (RBC) count is measured in x10^12/L
Baseline and 12 weeks
Hemoglobin (Hb)
Time Frame: Baseline and 12 weeks
Hemoglobin (Hb) is measured in g/dl
Baseline and 12 weeks
Hematocrit (Hct)
Time Frame: Baseline and 12 weeks
Hematocrit (Hct) is measured in %
Baseline and 12 weeks
Mean corpuscular volume (MCV)
Time Frame: Baseline and 12 weeks
Mean corpuscular volume (MCV) is measured in l/cell
Baseline and 12 weeks
Mean corpuscular hemoglobin (MCH)
Time Frame: Baseline and 12 weeks
Mean corpuscular hemoglobin (MCH) is measured in g/cell
Baseline and 12 weeks
Platelet (PLT) count
Time Frame: Baseline and 12 weeks
Platelet (PLT) count is measured in x10^9/L
Baseline and 12 weeks
Total cholesterol
Time Frame: Baseline and 12 weeks
Total cholesterol is measured in mmol/L
Baseline and 12 weeks
Low density lipoprotein (LDL)-cholesterol
Time Frame: Baseline and 12 weeks
Low density lipoprotein (LDL)-cholesterol is measured in mmol/L
Baseline and 12 weeks
High density lipoprotein (HDL)-cholesterol
Time Frame: Baseline and 12 weeks
High density lipoprotein (HDL)-cholesterol is measured in mmol/L
Baseline and 12 weeks
Triglyceride (Tg)
Time Frame: Baseline and 12 weeks
Triglyceride (Tg) is measured in mmol/L
Baseline and 12 weeks
Sodium level
Time Frame: Baseline and 12 weeks
Sodium level is measured in mmol/L
Baseline and 12 weeks
Potassium level
Time Frame: Baseline and 12 weeks
Potassium level is measured in mmol/L
Baseline and 12 weeks
Chloride level
Time Frame: Baseline and 12 weeks
Chloride level is measured in mmol/L
Baseline and 12 weeks
Blood urea nitrogen (BUN) level
Time Frame: Baseline and 12 weeks
Blood urea nitrogen (BUN) level is measured in mmol/L
Baseline and 12 weeks
Serum creatinine level
Time Frame: Baseline and 12 weeks
Serum creatinine level is measured in umol/L
Baseline and 12 weeks
Calcium level
Time Frame: Baseline and 12 weeks
Calcium level is measured in mmol/L
Baseline and 12 weeks
Uric acid level
Time Frame: Baseline and 12 weeks
Uric acid level is measured in umol/L
Baseline and 12 weeks
Phosphorus level
Time Frame: Baseline and 12 weeks
Phosphorus level is measured in mmol/L
Baseline and 12 weeks
Albumin
Time Frame: Baseline and 12 weeks
Albumin is measured in g/L
Baseline and 12 weeks
Total protein
Time Frame: Baseline and 12 weeks
Total protein is measured in g/L
Baseline and 12 weeks
Total bilirubin
Time Frame: Baseline and 12 weeks
Total bilirubin is measured in umol/L
Baseline and 12 weeks
Alkaline phosphatase (ALP)
Time Frame: Baseline and 12 weeks
Alkaline phosphatase (ALP) is measured in U/L
Baseline and 12 weeks
Alanine transaminase (ALT)
Time Frame: Baseline and 12 weeks
Alanine transaminase (ALT) is measured in U/L
Baseline and 12 weeks
Aspartate transaminase (AST)
Time Frame: Baseline and 12 weeks
Aspartate transaminase (AST) is measured in U/L
Baseline and 12 weeks
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
Baseline and 12 weeks
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
Baseline and 12 weeks
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
Baseline and 12 weeks
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
Baseline and 12 weeks
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
Baseline and 12 weeks
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
12 weeks
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.
12 weeks
Body fat
Time Frame: Baseline and 12 weeks
Body fat is measured in %
Baseline and 12 weeks
Fat mass
Time Frame: Baseline and 12 weeks
Fat mass is measured in %
Baseline and 12 weeks
Fat free mass
Time Frame: Baseline and 12 weeks
Fat free mass is measured in %
Baseline and 12 weeks
Total body water
Time Frame: Baseline and 12 weeks
Total body water is measured in L
Baseline and 12 weeks
Estimated average required energy
Time Frame: Baseline and 12 weeks
Estimated average required energy is measured in kcal
Baseline and 12 weeks
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.
At 4 weeks, 8 weeks and 12 weeks
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 %.
At 4 weeks, 8 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Sains Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lai Kuan Lee, PhD, Universiti Sains Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • USM/JEPeM/19010081

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Multigrain powder (S)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings