Effect of Dietary Fat Type in Combination With High Protein on Plasma Homocysteine Levels and Selected Markers of Cardiovascular Heart Disease Risk in Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Total homocysteine
研究概览
简要总结
In this study, the investigators address the research question of whether palm olein will have a positive influence on plasma total homocysteine levels in human volunteers provided with high-protein diets formulated from common Malaysian foods.
Hypothesis: There is a significant difference on the effects of the three experimental oils (palm olein, olive and coconut oil) on plasma tHy levels and the other markers of coronary heart disease (CHD) risk measured.
详细描述
The experimental are comprise of 30% kcal fat, 20% kcal protein and 50% kcal carbohydrate. Each of the test fat [palm olein (POo), virgin olive oil (OO) and coconut oil (CO)] contributes to two-thirds of total dietary fat will be compared.
Three meals a day providing 2000 kcal, including breakfast, lunch and dinner will be provided for the 5-weeks period of each fat rotation.
45 volunteers are fed with normal cooking oil for 3 weeks for standardisation purpose. They were then stratified into 3 groups according to gender, homocysteine and cholesterol level. The volunteers will be randomized, blinded and will undergo a 3 arms crossover intervention. Each intervention will take 5 wk with 2 wk wash out in between.
Baseline blood samples will be taken while other blood samples will be collected at week-4 and -5 of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy adult males and females aged 20-60 years, with BMI 23.0 -29.9 kg/m2, and free from any disease (will be decided through history taking, physical examination and biochemical tests).
- •Not on any medication or treatment associated with reduction of CHD.
- •Non-smokers and non heavy drinker or having smoking or alcoholic history.
- •Not pregnant or lactating.
- •Willing to adhere to the Dietary Guidelines to the study.
排除标准
- •Obese [Body Mass Index (BMI) ≥ 30] or grossly underweight (BMI < 18).
- •Suffering from chronic diseases such as diabetes mellitus, CHD, cancer or any liver/renal disease.
- •People with blood clotting problem.
- •Hypertensive persons (systolic pressure > 140 mmHg, diastolic pressure > 90 mmHg)
结局指标
主要结局
Total homocysteine
时间窗: 4th and 5th week
次要结局
- Lipids profile and inflammatory markers(4th and 5th weeks)