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

Phase 1

Completed

• Conditions: Lipid Disorder; Oxidative Stress; Diabetes Mellitus, Type 2; Glucose, High Blood
• Interventions: Biological: olive oil; Biological: bran oil

• Registration Number: NCT03544411
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study First Submitted: 2018-05-19
• Study First Submitted QC: 2018-05-19
• Study First Posted: 2018-06-01
• Study Start: 2018-07-02
• Primary Completion: 2018-09-20
• Status Verified: 2018-10
• Study Completion: 2018-10-05
• Last Update Submitted: 2018-10-13
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes Mellitus group 2	bran oil	this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Type 2 Diabetes Mellitus group 1	olive oil	The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Type 2 Diabetes Mellitus group 1	bran oil	The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Type 2 Diabetes Mellitus group 2	olive oil	this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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 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 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

Trial Locations

Locations (1)

Fkui-Kdk Kiara; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia