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| Name | Class |
|---|---|
| Fakultas Kedokteran Universitas Indonesia | OTHER |
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This study determines the effect of olive oil and bran oil on antioxidant levels, and glycemic control in patients with type 2 diabetes mellitus (DM)
Intervention: Patient type 2 DM will receive olive oil and bran oil with cross over study
Diabetes mellitus (DM) has become one of the global public health problems. The chronic complications of type 2 DM can be macrovascular and microvascular complications that can decrease the quality of life of the patient. The main goal of sustainable DM nutrition therapy is to keep glucose in the blood close to normal levels to stop hyperglycemic and hyperlipidemic events that may inhibit further complications
This study was a clinical trial with cross over study design, random allocation, and double blindness to compare changes in antioxidant, glucose, cholesterol and triglyceride levels supplemented with 15 ml / day of olive oil (KZ) with supplementation of 15 ml / day of bran oil (KB). Provision of oil for 4 weeks in a row. During the 2-week interval not being treated (wash out). After the wash out period cross-over by exchanging olive oil supplementation to rice bran and vice versa for 4 consecutive weeks. The research will be conducted at Family Clinic Clinic FKUI Kayu Putih, Jakarta.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 Diabetes Mellitus group 1 | Experimental | The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil |
|
| Type 2 Diabetes Mellitus group 2 | Experimental | this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olive oil | Biological | the intervention consist of 15 ml / day of olive oil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of malondialdehyde | Change from baseline malondialdehyde at 4 weeks and at 10 weeks, is measured in pmol/mL | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of fasting plasma glucose | Change from baseline fasting plasma glucose at 4 weeks and at 10 weeks, is measured in mg/dL | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Change of post prandial blood glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dwirini R Gunarti, DR | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fkui-Kdk Kiara | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| D000073879 | Rice Bran Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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This study was a clinical trial with cross over study design, random allocation, and double blindness to compare changes in antioxidant, glucose, cholesterol and triglyceride levels supplemented with 15 ml / day of olive oil (KZ) with supplementation of 15 ml / day of bran oil (KB). Provision of oil for 4 weeks in a row. During the 2-week interval not being treated (wash out). After the wash out period cross-over by exchanging olive oil supplementation to rice bran and vice versa for 4 consecutive weeks.
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| bran oil | Biological | the intervention consist of 15 ml / day of bran oil |
|
Change from baseline post prandial blood glucose at 4 weeks and at 10 weeks, is measured in mg/dL
| baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Change of total cholesterol | Change from baseline cholesterol at 4 weeks and at 10 weeks, is measured in mg/dL | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Change of Low density lipoprotein | Change from baseline Low density lipoprotein at 4 weeks and at 10 weeks, is measured in mg/dL | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Change of High density lipoprotein | Change from baseline High density lipoprotein at 4 weeks and at 10 weeks, is measured in mg/dL | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Change of Trygliseride | Change from baseline trygliseride at 4 weeks and at 10 weeks, is measured in mg/dL | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Change of Katalase | Change from baseline katalase at 4 weeks and at 10 weeks, is measured in unit/ mg protein | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Change of Superoxide Dismutase | Change from baseline superoxide dismutase at 4 weeks and at 10 weeks, is measured in unit/ mg protein | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| Change of Glutahione | Change from baseline gluthatione at 4 weeks and at 10 weeks, is measured in nmol/ gram | baseline at Day0 and ,midline at Day28 and endline at Day70 |
| D004700 | Endocrine System Diseases |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |