Diabetes Mellitus, Type 2, Glucose, High Blood, Lipid Disorder, Oxidative Stress
Conditions
Keywords
Olive oil, Bran oil, Type 2 Diabetes Mellitus, Antioxidant, glycemic control, lipid profile
Brief summary
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
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.
Interventions
BIOLOGICALolive oil
the intervention consist of 15 ml / day of olive oil
BIOLOGICALbran oil
the intervention consist of 15 ml / day of bran oil
Sponsors
Fakultas Kedokteran Universitas Indonesia
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of malondialdehyde | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline malondialdehyde at 4 weeks and at 10 weeks, is measured in pmol/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of post prandial blood glucose | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline post prandial blood glucose at 4 weeks and at 10 weeks, is measured in mg/dL |
| Change of total cholesterol | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline cholesterol at 4 weeks and at 10 weeks, is measured in mg/dL |
| Change of Low density lipoprotein | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline Low density lipoprotein at 4 weeks and at 10 weeks, is measured in mg/dL |
| Change of High density lipoprotein | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline High density lipoprotein at 4 weeks and at 10 weeks, is measured in mg/dL |
| Change of fasting plasma glucose | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline fasting plasma glucose at 4 weeks and at 10 weeks, is measured in mg/dL |
| Change of Katalase | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline katalase at 4 weeks and at 10 weeks, is measured in unit/ mg protein |
| Change of Superoxide Dismutase | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline superoxide dismutase at 4 weeks and at 10 weeks, is measured in unit/ mg protein |
| Change of Glutahione | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline gluthatione at 4 weeks and at 10 weeks, is measured in nmol/ gram |
| Change of Trygliseride | baseline at Day0 and ,midline at Day28 and endline at Day70 | Change from baseline trygliseride at 4 weeks and at 10 weeks, is measured in mg/dL |
Countries
Indonesia
Outcome results
None listed