Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

Not Applicable

Completed

• Conditions: Type2 Diabetes
• Interventions: Dietary Supplement: Instant multigrain supplement

• Registration Number: NCT04597229
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

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.

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 Timeline

• Study Start: 2020-09-28
• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Primary Completion: 2021-05-26
• Status Verified: 2021-06
• Study Completion: 2021-06-14
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Instant multigrain	Instant multigrain supplement	Oral instant multigrain supplement

Primary Outcome Measures

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

Trial Locations

Locations (1)

Advanced Medical and Dental Institute (AMDI); 🇲🇾 Kepala Batas, Pulau Pinang, Malaysia