Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus: A Randomized Human Clinical Trial

The objective of this study is to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Dietary supplement: Instant multigrain supplement

Detailed Description

Type II DM is a highly prevalent and heterogeneous condition. New treatment modalities to complement existing interventions are therefore of great interest, including dietary interventions for primary prevention or as a possible therapeutic option that may confer benefits beyond currently recommended conventional therapies. Hence, the present work aims to evaluate the efficacy of instant multigrain supplementation on the glycemic status, cardiometabolic implications, oxidative stress and nutritional status in Type II DM patients, as compare to standardized medication regimen.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Pulau Pinang
    • Kepala Batas, Pulau Pinang, Malaysia, 13200
      • Advanced Medical and Dental Institute (AMDI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria for the clinical trial are:

• Clinical diagnosis with Type II DM for at least 6 months' duration without clinically manifest complications (retinopathy, diabetic nephropathy, vascular diseases, foot ulcer - as diagnosed by the physician/recorded in database)
• Male or female
• Pharmacological treatment with metformin or insulin, or a combination of metformin and glibenclamide.
• Chronological age: 18 years and above
• Metabolically stable (current laboratory results for A1C 6.0-8.5%; or fasting plasma glucose 6.4-8.5 mmol/l)
• Not taking antioxidant/anti-inflammatory 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), and endocrine disorders (Cushing's disease, gigantism and hyperthyroidism).
• Alcohol and drug abuse (self-mentioned or as recorded in the medical card)
• Gestational Diabetes Mellitus
• 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)
• Use of steroids, chemotherapy, immunosuppressant or radiotherapy.
• Vegetarian patient (pure vegan)
• Gluten intolerance
• Participations currently under another supplementary program

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Instant multigrain; Oral instant multigrain supplement	Dietary supplement: Instant multigrain supplement; A twice daily instant multigrain supplementation for 12 weeks
No Intervention: Standard care; Standard care without oral instant multigrain supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Glycated haemoglobin (HbA1c)	Glycated hemoglobin (HbA1c) is measured in %	Baseline and 12 weeks
Change of fasting serum insulin	Fasting serum insulin will be measured by radioimmunoassay kit	Baseline and 12 weeks
Change of fasting plasma glucose (FPG)	Glycated hemoglobin (HbA1c) is measured in mmol/L	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2020
• Primary Completion (Actual): May 26, 2021
• Study Completion (Actual): June 14, 2021

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 20, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: June 14, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: LLKuan

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