Effectiveness of Multigrain Supplementation Among the Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033809
• Other study ID #: USM/JEPeM/19010081
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2023
• Source: Universiti Sains Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 31, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Dietary Supplement:
• Multigrain powder (S)
A twice daily high fiber multigrain powder supplementation for 12 weeks

Locations

Country	Name	City	State
Malaysia	Universiti Sains Malaysia	Kubang Kerian	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
Universiti Sains Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Blood glucose level	Blood glucose is measured in mmol/L	Baseline and 12 weeks
Secondary	Glycated hemoglobin (HbA1c)	Glycated hemoglobin (HbA1c) is measured in %	Baseline and 12 weeks
Secondary	White blood cell (WBC) count	White blood cell (WBC) differential count is measured in x10^9/L	Baseline and 12 weeks
Secondary	Red blood cell (RBC) count	Red blood cell (RBC) count is measured in x10^12/L	Baseline and 12 weeks
Secondary	Hemoglobin (Hb)	Hemoglobin (Hb) is measured in g/dl	Baseline and 12 weeks
Secondary	Hematocrit (Hct)	Hematocrit (Hct) is measured in %	Baseline and 12 weeks
Secondary	Mean corpuscular volume (MCV)	Mean corpuscular volume (MCV) is measured in l/cell	Baseline and 12 weeks
Secondary	Mean corpuscular hemoglobin (MCH)	Mean corpuscular hemoglobin (MCH) is measured in g/cell	Baseline and 12 weeks
Secondary	Platelet (PLT) count	Platelet (PLT) count is measured in x10^9/L	Baseline and 12 weeks
Secondary	Total cholesterol	Total cholesterol is measured in mmol/L	Baseline and 12 weeks
Secondary	Low density lipoprotein (LDL)-cholesterol	Low density lipoprotein (LDL)-cholesterol is measured in mmol/L	Baseline and 12 weeks
Secondary	High density lipoprotein (HDL)-cholesterol	High density lipoprotein (HDL)-cholesterol is measured in mmol/L	Baseline and 12 weeks
Secondary	Triglyceride (Tg)	Triglyceride (Tg) is measured in mmol/L	Baseline and 12 weeks
Secondary	Sodium level	Sodium level is measured in mmol/L	Baseline and 12 weeks
Secondary	Potassium level	Potassium level is measured in mmol/L	Baseline and 12 weeks
Secondary	Chloride level	Chloride level is measured in mmol/L	Baseline and 12 weeks
Secondary	Blood urea nitrogen (BUN) level	Blood urea nitrogen (BUN) level is measured in mmol/L	Baseline and 12 weeks
Secondary	Serum creatinine level	Serum creatinine level is measured in umol/L	Baseline and 12 weeks
Secondary	Calcium level	Calcium level is measured in mmol/L	Baseline and 12 weeks
Secondary	Uric acid level	Uric acid level is measured in umol/L	Baseline and 12 weeks
Secondary	Phosphorus level	Phosphorus level is measured in mmol/L	Baseline and 12 weeks
Secondary	Albumin	Albumin is measured in g/L	Baseline and 12 weeks
Secondary	Total protein	Total protein is measured in g/L	Baseline and 12 weeks
Secondary	Total bilirubin	Total bilirubin is measured in umol/L	Baseline and 12 weeks
Secondary	Alkaline phosphatase (ALP)	Alkaline phosphatase (ALP) is measured in U/L	Baseline and 12 weeks
Secondary	Alanine transaminase (ALT)	Alanine transaminase (ALT) is measured in U/L	Baseline and 12 weeks
Secondary	Aspartate transaminase (AST)	Aspartate transaminase (AST) is measured in U/L	Baseline and 12 weeks
Secondary	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	Baseline and 12 weeks
Secondary	Serum interleukin 1ß (IL-1ß)	Interleukin 1ß is among the most important proin?ammatory cytokines in rheumatoid arthritis. Serum IL-1ß is measured in pg/ml	Baseline and 12 weeks
Secondary	Tumor necrosis factor-alpha (TNF-a)	Tumor necrosis factor-alpha (TNF-a) is a proinflammatory cytokine that plays a pivotal role in regulating the inflammatory response in rheumatoid arthritis. Serum IL-1ß is measured in pg/ml	Baseline and 12 weeks
Secondary	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	Baseline and 12 weeks
Secondary	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	Baseline and 12 weeks
Secondary	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	12 weeks
Secondary	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.	12 weeks
Secondary	Body fat	Body fat is measured in %	Baseline and 12 weeks
Secondary	Fat mass	Fat mass is measured in %	Baseline and 12 weeks
Secondary	Fat free mass	Fat free mass is measured in %	Baseline and 12 weeks
Secondary	Total body water	Total body water is measured in L	Baseline and 12 weeks
Secondary	Estimated average required energy	Estimated average required energy is measured in kcal	Baseline and 12 weeks
Secondary	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.	At 4 weeks, 8 weeks and 12 weeks
Secondary	Compliance assessment	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