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

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Indonesia
Study Type
Interventional
Intervention
olive oil
bran oil
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Olive oil, Bran oil, Type 2 Diabetes Mellitus, Antioxidant, glycemic control, lipid profile

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fkui-Kdk Kiara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Type 2 Diabetes Mellitus group 1

Type 2 Diabetes Mellitus group 2

Arm Description

The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil

this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change of fasting plasma glucose
Change from baseline fasting plasma glucose at 4 weeks and at 10 weeks, is measured in mg/dL
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
Change of total cholesterol
Change from baseline cholesterol at 4 weeks and at 10 weeks, is measured in mg/dL
Change of Low density lipoprotein
Change from baseline Low density lipoprotein at 4 weeks and at 10 weeks, is measured in mg/dL
Change of High density lipoprotein
Change from baseline High density lipoprotein at 4 weeks and at 10 weeks, is measured in mg/dL
Change of Trygliseride
Change from baseline trygliseride at 4 weeks and at 10 weeks, is measured in mg/dL
Change of Katalase
Change from baseline katalase at 4 weeks and at 10 weeks, is measured in unit/ mg protein
Change of Superoxide Dismutase
Change from baseline superoxide dismutase at 4 weeks and at 10 weeks, is measured in unit/ mg protein
Change of Glutahione
Change from baseline gluthatione at 4 weeks and at 10 weeks, is measured in nmol/ gram

Full Information

First Posted
May 19, 2018
Last Updated
October 13, 2018
Sponsor
Indonesia University
Collaborators
Fakultas Kedokteran Universitas Indonesia
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1. Study Identification

Unique Protocol Identification Number
NCT03544411
Brief Title
Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM
Official Title
Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Diabetes Mellitus Type 2
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Fakultas Kedokteran Universitas Indonesia

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Oxidative Stress, Glucose, High Blood, Lipid Disorder
Keywords
Olive oil, Bran oil, Type 2 Diabetes Mellitus, Antioxidant, glycemic control, lipid profile

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 2 Diabetes Mellitus group 1
Arm Type
Experimental
Arm Description
The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Arm Title
Type 2 Diabetes Mellitus group 2
Arm Type
Experimental
Arm Description
this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Intervention Type
Biological
Intervention Name(s)
olive oil
Intervention Description
the intervention consist of 15 ml / day of olive oil
Intervention Type
Biological
Intervention Name(s)
bran oil
Intervention Description
the intervention consist of 15 ml / day of bran oil
Primary Outcome Measure Information:
Title
Change of malondialdehyde
Description
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 Outcome Measure Information:
Title
Change of fasting plasma glucose
Description
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
Title
Change of post prandial blood glucose
Description
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
Title
Change of total cholesterol
Description
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
Title
Change of Low density lipoprotein
Description
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
Title
Change of High density lipoprotein
Description
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
Title
Change of Trygliseride
Description
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
Title
Change of Katalase
Description
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
Title
Change of Superoxide Dismutase
Description
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
Title
Change of Glutahione
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dwirini R Gunarti, DR
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fkui-Kdk Kiara
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

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

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