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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03544411
• Other study ID #: BeZaproject
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2018
• Est. completion date: October 5, 2018

Study information

• Verified date: October 2018
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 5, 2018
• Est. primary completion date: September 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose, High Blood
• Hyperglycemia
• Lipid Disorder
• Lipid Metabolism Disorders
• Oxidative Stress

Intervention

Biological:
• olive oil
the intervention consist of 15 ml / day of olive oil
• bran oil
the intervention consist of 15 ml / day of bran oil

Locations

Country	Name	City	State
Indonesia	Fkui-Kdk Kiara	Jakarta Pusat	DKI Jakarta

Sponsors (2)

Lead Sponsor	Collaborator
Indonesia University	Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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