Efficacy of Multigrain Supplementation in Type II Diabetes Mellitus

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type2 Diabetes

Intervention / Treatment
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* Dietary Supplement: Instant multigrain supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Instant multigrain<br>Oral instant multigrain supplement | Dietary Supplement: Instant multigrain supplement<br>* A twice daily instant multigrain supplementation for 12 weeks<br>|
| No Intervention: Standard care<br>Standard care without oral instant multigrain supplement | |

What is the study measuring?
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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 plasma glucose (FPG) | Glycated hemoglobin (HbA1c) is measured in mmol/L | Baseline and 12 weeks | 
| Change of fasting serum insulin | Fasting serum insulin will be measured by radioimmunoassay kit | Baseline and 12 weeks |