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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Oxidative Stress; Lipid Disorder; Glucose, High Blood
• Intervention / Treatment: Biological: olive oil; Biological: bran oil

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Fkui-Kdk Kiara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Type 2 Diabetes Mellitus group 1; The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil	Biological: olive oil; the intervention consist of 15 ml / day of olive oil; Biological: bran oil; the intervention consist of 15 ml / day of bran oil
EXPERIMENTAL: Type 2 Diabetes Mellitus group 2; this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil	Biological: olive oil; the intervention consist of 15 ml / day of olive oil; Biological: bran oil; the intervention consist of 15 ml / day of bran oil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Dwirini R Gunarti, DR, Indonesia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2018
• Primary Completion (ACTUAL): September 20, 2018
• Study Completion (ACTUAL): October 5, 2018

Study Registration Dates

• First Submitted: May 19, 2018
• First Submitted That Met QC Criteria: May 19, 2018
• First Posted (ACTUAL): June 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 13, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus; Antioxidant; glycemic control; lipid profile; Olive oil; Bran oil
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Lipid Metabolism Disorders
• Other Study ID Numbers: BeZaproject

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No