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NCT Number: NCT03544411

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

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Glucose, High Blood Lipid Disorder Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Oxidative Stress

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fkui-Kdk Kiara

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

olive oil

Biological

the intervention consist of 15 ml / day of olive oil

bran oil

Biological

the intervention consist of 15 ml / day of bran oil

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Fakultas Kedokteran Universitas Indonesia

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2018
Registry last updated
Oct 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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