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

U

University of Indonesia (UI)

Status and phase

Completed
Phase 1

Conditions

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

Treatments

Biological: bran oil
Biological: olive oil

Study type

Interventional

Funder types

Other

Identifiers

NCT03544411
BeZaproject

Details and patient eligibility

About

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

Full 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.

Enrollment

10 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

10 participants in 2 patient groups

Type 2 Diabetes Mellitus group 1
Experimental group
Description:
The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Treatment:
Biological: olive oil
Biological: bran oil
Type 2 Diabetes Mellitus group 2
Experimental group
Description:
this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
Treatment:
Biological: olive oil
Biological: bran oil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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