Effect of Extra Virgin Olive Oil on Postprandial Blood Glucose in Type 2 Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- trans-meal blood glucose
研究概览
简要总结
Extra virgin olive oil (EVOO) is known for its cardiovascular effects and its effect on glucose lowering. However, the effects of EVOO on the blood glucose of Type 2 Diabetes Mellitus Filipino patients has not been studied. The investigators aimed to determine whether a significant difference exists in meals containing EVOO versus meals without EVOO among Type 2 Diabetes Mellitus patients.
Thirteen patients were included in this randomized controlled cross-over trial. They were randomized to receive a meal with or without EVOO followed by a one week wash out period, where they were given the other intervention. The primary outcome is the trans-meal blood glucose, which is calculated as the percent change in 2-hour postprandial blood glucose.
详细描述
During their first visit, the participants were oriented on the conduct of the study. They were advised to be compliant with their medications throughout the duration of the trial.
On their second visit, participants were asked to do a six to eight-hour overnight fast, and their fasting blood sugar was drawn. Serum samples were analyzed through the hexokinase method. The participants were then randomly allocated (first allocation) by the dietician through a coin toss to receive a standard breakfast without EVOO or a meal admixed with one tablespoon of EVOO. The standard meals were labeled with serial numbers, and both the participants and the investigator were blinded to the intervention. The meals were consumed steadily in 15 to 20 minutes, after which, the food containers were collected to ensure its full consumption. Breakfast was chosen in order to avoid a second meal bias. The participants were asked to sit in the waiting area of the laboratory until the 2-hour postprandial blood sugar was due to be drawn.
After a one-week washout period, the participants were asked to come back for a cross over to the other treatment arm (second allocation). The participants were given the same test meal to ensure that that the glycemic index of the food remained constant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged 30-65 years old
- •diagnosed with Type 2 Diabetes Mellitus
- •body mass index under the overweight or obese class I category (by Asia Pacific guidelines)
排除标准
- •pregnant patients
- •patients with history of frequent hypoglycemic episodes
- •those at high risk of developing ketoacidosis and hyperglycemic hyperosmolar syndrome
- •those with identified acute stress during the study (illness, fever, trauma leading to hospitalization)
- •current intake of steroids
- •olive oil allergy or intolerance
- •digestive disorders
研究组 & 干预措施
Group A
Initially received the test meal with EVOO, then on crossover, received the meal without EVOO
干预措施: Extra Virgin Olive Oil (EVOO) (Dietary Supplement)
Group B
Initially received the test meal without EVOO, then on crossover, received the meal without EVOO
结局指标
主要结局
trans-meal blood glucose
时间窗: 2 hours
percent change in 2-hour postprandial blood glucose. This was calculated as the fasting blood sugar subtracted from the 2-hour postprandial glucose divided by the fasting blood sugar multiplied by 100
次要结局
未报告次要终点
研究者
Daphne Gayle P Galang
Fellow, Section of Endocrinology, Department of Internal Medicine
Makati Medical Center