Clinical trial NCT03544411: Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Type 2 DM
Official title: Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Oxidative Stress
Glucose, High Blood
Lipid Disorder
Keywords: Olive oil
Bran oil
Type 2 Diabetes Mellitus
Antioxidant
glycemic control
lipid profile
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
First posted: 2018-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Change of malondialdehyde
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
Secondary outcomes:
measure: Change of fasting plasma glucose
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
measure: Change of post prandial blood glucose
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
measure: Change of total cholesterol
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
measure: Change of Low density lipoprotein
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
measure: Change of High density lipoprotein
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
measure: Change of Trygliseride
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
measure: Change of Katalase
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
measure: Change of Superoxide Dismutase
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
measure: Change of Glutahione
timeFrame: baseline at Day0 and ,midline at Day28 and endline at Day70
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Fkui-Kdk Kiara
state: DKI Jakarta
Study officials:
affiliation: Indonesia University
name: Dwirini R Gunarti, DR
role: PRINCIPAL_INVESTIGATOR
References: