Effects of Olive Oil and Bran Oil on Antioxidant Levels, Glycemic Control, and Lipid Profile in Patient Diabetes Mellitus Type 2
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change of malondialdehyde
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Type 2 Diabetes Mellitus group 1
The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
干预措施: bran oil (Biological)
Type 2 Diabetes Mellitus group 2
this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
干预措施: bran oil (Biological)
Type 2 Diabetes Mellitus group 2
this group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
干预措施: olive oil (Biological)
Type 2 Diabetes Mellitus group 1
The group supplemented with 15 ml / day of olive oil and 15 ml / day of bran oil
干预措施: olive oil (Biological)
结局指标
主要结局
Change of malondialdehyde
时间窗: 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
次要结局
- Change of total cholesterol(baseline at Day0 and ,midline at Day28 and endline at Day70)
- Change of Low density lipoprotein(baseline at Day0 and ,midline at Day28 and endline at Day70)
- Change of High density lipoprotein(baseline at Day0 and ,midline at Day28 and endline at Day70)
- Change of Trygliseride(baseline at Day0 and ,midline at Day28 and endline at Day70)
- Change of Katalase(baseline at Day0 and ,midline at Day28 and endline at Day70)
- Change of fasting plasma glucose(baseline at Day0 and ,midline at Day28 and endline at Day70)
- Change of post prandial blood glucose(baseline at Day0 and ,midline at Day28 and endline at Day70)
- Change of Superoxide Dismutase(baseline at Day0 and ,midline at Day28 and endline at Day70)
- Change of Glutahione(baseline at Day0 and ,midline at Day28 and endline at Day70)
研究者
Rina Agustina
Head of Human Nutrition Research Centre
Indonesia University