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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Instant multigrain | Active Comparator | Oral instant multigrain supplement |
|
| Standard care | No Intervention | Standard care without oral instant multigrain supplement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Instant multigrain supplement | Dietary Supplement | A twice daily instant multigrain supplementation for 12 weeks |
|
| 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 |
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Inclusion Criteria:
Inclusion criteria for the clinical trial are:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Medical and Dental Institute (AMDI) | Kepala Batas | Pulau Pinang | 13200 | Malaysia |
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