Chronic Effects of Natural Palm-based Margarine and Interesterified Palm- and Soy-based Margarine on Insulin Sensitivity and Selected Markers of Cardiovascular Diseases (CVD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Change in serum C-peptide level of subject
研究概览
简要总结
The investigators hypothesized that there will be a significant difference between the effects of trans-free palm-, interesterified palm- and interesterified soybean oil blend on cardiovascular disease, inflammation, insulin resistance and obesity.
详细描述
Human volunteers will be conditioned for a 8 wk intervention on 3 different test diets providing 30 % energy as fat, 15% energy as protein and 55% energy as carbohydrate according to parallel designed sequences. The test fats used for this study are palm oil, chemically interesterified palm oil and chemically interesterified fully hydrogenated soybean oil and soft oil blend in the form of margarine. Volunteers will be restricted to follow the dietary guidelines throughout the study. Blood collection sessions will held before and after every diet intervention. Outcome measures of the study are serum lipid profile, markers of inflammation, markers of obesity and insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Adult males and females, aged 20-60 yr
- •Staff and students of International Medical University, IMU/ Staff of Malaysian Palm Oil Board, MPOB to facilitate centralized consumption of the test fats/snacks
- •BMI 21 - 30 kg/m2
排除标准
- •Abnomal liver function test (elevated transaminases- alanine aminotransferase,ALT; aspartate aminotransferase,AST))/ abnormal kidney function test (elevated plasma creatinine)
- •History of type 2 diabetes mellitus, cancer, stomach ulcers, drug abuse or alcoholism
- •On lipid/blood pressure- lowering medication/supplements
- •Blood pressure>140/90 mmHg
- •Fasting total cholesterol > 6.5 mmol/L
- •Fasting TAG > 2.0 mmol/L
- •Candidates who are going abroad during the planned schedule for the dietary intervention
结局指标
主要结局
Change in serum C-peptide level of subject
时间窗: up to 8 weeks
次要结局
- Change in serum lipid profile(up to 8 weeks)
- Change in markers of inflammation(up to 8 weeks)
- Change in markers of obesity(up to 8 weeks)
- Change in markers of insulin resistance(up to 8 weeks)
- Oral Glucose tolerance test (OGTT)(Baseline, month-2)