Type2 Diabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTInstant multigrain supplement
A twice daily instant multigrain supplementation for 12 weeks
Sponsors
Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change of fasting serum insulin | Baseline and 12 weeks | Fasting serum insulin will be measured by radioimmunoassay kit |
Countries
Malaysia
Outcome results
None listed