Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Diabetes Mellitus Type 2

Conditions
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Diabetes Mellitus, Type 2, Oxidative Stress, Glucose, High Blood, Lipid Disorder

Intervention / Treatment
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* Biological: olive oil
* Biological: bran oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with type 2 diabetes aged 30-60 years. Diagnosed type 2 DM <3 years. Body mass index of 20-30 kg / m2 Subjects willing to participate in research and sign informed consent. Drinking OHO (oral hyperglycemic medication). Exclusion Criteria: There are acute and chronic complications. Subject is pregnant. Get cholesterol-lowering drugs, steroids and other drugs that affect the metabolism of fat. Smoking more than 10 cigarettes / day. Eat regular supplements that contain phytosterols or other antioxidants that are known by anamnesis. Has a disorder or gastrointestinal disease, thyroid, heart, liver, cancer, stroke and kidney are known with medical record data.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Type 2 Diabetes Mellitus group 1<br>The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil | Biological: olive oil<br>* the intervention consist of 15 ml / day of olive oil<br>Biological: bran oil<br>* the intervention consist of 15 ml / day of bran oil<br>|
| Experimental: Type 2 Diabetes Mellitus group 2<br>this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil | Biological: olive oil<br>* the intervention consist of 15 ml / day of olive oil<br>Biological: bran oil<br>* the intervention consist of 15 ml / day of bran oil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Antioxidant, glycemic control, lipid profile, Olive oil, Bran oil