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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03544411
Recruitment Status : Completed
First Posted : June 1, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Fakultas Kedokteran Universitas Indonesia
Information provided by (Responsible Party):
Rina Agustina, 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


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Oxidative Stress Glucose, High Blood Lipid Disorder Biological: olive oil Biological: bran oil Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Diabetes Mellitus Type 2
Actual Study Start Date : July 2, 2018
Actual Primary Completion Date : September 20, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants
Drug Information available for: Olive oil

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




Primary Outcome Measures :
  1. Change of malondialdehyde [ Time Frame: 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 :
  1. Change of fasting plasma glucose [ Time Frame: 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

  2. Change of post prandial blood glucose [ Time Frame: 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

  3. Change of total cholesterol [ Time Frame: 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

  4. Change of Low density lipoprotein [ Time Frame: 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

  5. Change of High density lipoprotein [ Time Frame: 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

  6. Change of Trygliseride [ Time Frame: 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

  7. Change of Katalase [ Time Frame: 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

  8. Change of Superoxide Dismutase [ Time Frame: 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

  9. Change of Glutahione [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03544411


Locations
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Indonesia
Fkui-Kdk Kiara
Jakarta Pusat, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Fakultas Kedokteran Universitas Indonesia
Investigators
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Principal Investigator: Dwirini R Gunarti, DR Indonesia University
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Responsible Party: Rina Agustina, Head of Human Nutrition Research Centre, Indonesia University
ClinicalTrials.gov Identifier: NCT03544411    
Other Study ID Numbers: BeZaproject
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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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
Keywords provided by Rina Agustina, Indonesia University:
Olive oil
Bran oil
Type 2 Diabetes Mellitus
Antioxidant
glycemic control
lipid profile
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Lipid Metabolism Disorders
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases