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

• Sponsor: Indonesia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03544411
• Collaborator: Fakultas Kedokteran Universitas Indonesia (Other)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 3.2

Study Details

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
• 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.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: Jul 2, 2018
• Actual Primary Completion Date: Sep 20, 2018
• Actual Study Completion Date: Oct 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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 30 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rina Agustina, Head of Human Nutrition Research Centre, Indonesia University
• ClinicalTrials.gov Identifier: NCT03544411
• Other Study ID Numbers: BeZaproject
• First Posted: Jun 1, 2018
• Last Update Posted: Oct 16, 2018
• Last Verified: Oct 1, 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, Head of Human Nutrition Research Centre, 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

Study Results

No Results Posted as of Oct 16, 2018