Effect of Domestic Consumption of High Oleic Palm Oil on Cardiovascular Risk Biomarkers in Adults in Bogotá, DC
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Lipid profile
研究概览
简要总结
This randomized clinical trial aims to evaluate the effects of refined high-oleic palm oil consumption on cardiovascular risk biomarkers and insulin resistance in healthy adults. Participants will be randomly assigned to two groups to consume either high-oleic palm oil or olive oil for four months in typical domestic preparations.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years
- •Stable medication dosages (if applicable)
- •Signed informed consent
排除标准
- •o Use of nutritional supplements
- •Uncontrolled chronic diseases (e.g., diabetes, chronic kidney disease)
- •Allergies to palm oil or olive oil
研究组 & 干预措施
Refined High Oleic Palm Oil (APAOr)
Twenty-six participants were assigned to receive refined high oleic palm oil (APAOr) as the exclusive edible cooking oil for household food preparation. Participants received approximately 1.5 L of oil per month and were instructed to use only the assigned oil during the 4-month intervention period.
干预措施: High-oleic palm oil (Other)
Olive Oil Group (AO)
Twenty participants were assigned to receive olive oil (AO) as the exclusive edible cooking oil for household food preparation. Participants received approximately 1.5 L of oil per month and were instructed to use only the assigned oil during the 4-month intervention period.
干预措施: High-oleic palm oil (Other)
结局指标
主要结局
Lipid profile
时间窗: From the start of the intervention until the last data point is 4 months. Biochemical laboratory tests are performed every two months, meaning a total of three data points will be collected (initial, intermediate, and final).
Plasma levels of cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, and apolipoprotein B
Changes in Biomarkers of Glycemic Control and Insulin Resistance
时间窗: Duration of the intervention: four months, with three laboratory analyses: baseline analysis at 0 month, mid-term analysis at two months, and final analysis at four months.
To evaluate the effect of high-oleic palm oil consumption compared to olive oil on fasting glucose, glycated hemoglobin (HbA1c), fasting insulin, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR index), and triglyceride-glucose (TyG) index as indicators of metabolic control and insulin sensitivity.
次要结局
- Liver function(Intervention duration: four months, with three laboratory tests: initial test at month zero, intermediate test at two months, and final test at four months.)
- Changes in Plasma Apolipoprotein B Levels(4 months: Baseline (Month 0), Month 2, and Month 4 of intervention.)
- Changes in the ApoB/LDL-C Atherogenic Index(Intervention 4 months: Baseline (Month 0), Month 2, and Month 4 of intervention.)
研究者
Ruby Alejandra Villamil
Principal Investigator; Master in Biological Sciences and Ph.D. in Biological Sciences at PUJ-Bogotá.
Pontificia Universidad Javeriana