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

Universitas Indonesia10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

olive oilBIOLOGICAL

the intervention consist of 15 ml / day of olive oil

bran oilBIOLOGICAL

the intervention consist of 15 ml / day of bran oil

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fkui-Kdk Kiara

Jakarta Pusat, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Change of malondialdehyde

Change from baseline malondialdehyde at 4 weeks and at 10 weeks, is measured in pmol/mL

Time frame: baseline at Day0 and ,midline at Day28 and endline at Day70

Secondary Outcomes

Change of fasting plasma glucose

Change from baseline fasting plasma glucose at 4 weeks and at 10 weeks, is measured in mg/dL

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: baseline at Day0 and ,midline at Day28 and endline at Day70

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Phase 1CompletedNCT03544411

Universitas Indonesia10 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

olive oilBIOLOGICAL

the intervention consist of 15 ml / day of olive oil

bran oilBIOLOGICAL

the intervention consist of 15 ml / day of bran oil

Eligibility

Sex: ALLMin age: 30 YearsMax age: 60 Years

Medical Language ↔ Plain English

Locations (1)

Fkui-Kdk Kiara

Jakarta Pusat, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

Change of malondialdehyde

Change from baseline malondialdehyde at 4 weeks and at 10 weeks, is measured in pmol/mL

Time frame: baseline at Day0 and ,midline at Day28 and endline at Day70

Secondary Outcomes

Change of fasting plasma glucose

Change from baseline fasting plasma glucose at 4 weeks and at 10 weeks, is measured in mg/dL

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: baseline at Day0 and ,midline at Day28 and endline at Day70

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.