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

• ClinicalTrials.gov Identifier: NCT03544411
• Recruitment Status: Completed
• First Posted: June 1, 2018
• Last Update Posted: October 16, 2018
• Sponsor: Indonesia University
• Collaborator: Fakultas Kedokteran Universitas Indonesia
• Information provided by (Responsible Party): Rina Agustina, Indonesia University

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

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Locations

Indonesia

Fkui-Kdk Kiara

Jakarta Pusat, DKI Jakarta, Indonesia, 10430

Sponsors and Collaborators

Indonesia University

Fakultas Kedokteran Universitas Indonesia

Investigators

• Principal Investigator: Dwirini R Gunarti, DR; Indonesia University

More Information

• 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
• Last Update Posted: October 16, 2018
• Last Verified: October 2018

• 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:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Lipid Metabolism Disorders; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases