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

NCT ID: NCT03544411

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2018-10-05

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Type 2 Diabetes Mellitus group 1

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

Group Type EXPERIMENTAL

olive oil

Intervention Type BIOLOGICAL

the intervention consist of 15 ml / day of olive oil

bran oil

Intervention Type BIOLOGICAL

the intervention consist of 15 ml / day of bran oil

Type 2 Diabetes Mellitus group 2

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

Group Type EXPERIMENTAL

olive oil

Intervention Type BIOLOGICAL

the intervention consist of 15 ml / day of olive oil

bran oil

Intervention Type BIOLOGICAL

the intervention consist of 15 ml / day of bran oil

Interventions

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olive oil

the intervention consist of 15 ml / day of olive oil

Intervention Type BIOLOGICAL

bran oil

the intervention consist of 15 ml / day of bran oil

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fakultas Kedokteran Universitas Indonesia

OTHER

Sponsor Role collaborator

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Rina Agustina

Head of Human Nutrition Research Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dwirini R Gunarti, DR

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Fkui-Kdk Kiara

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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BeZaproject

Identifier Type: -

Identifier Source: org_study_id

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