Evaluation of the Effect of Consuming Yogurts Fortified With Dietary Sources of Vitamin E and Omega-3 on Classical Biomarkers of Cardiovascular Disease and Blood Levels of Vitamin E.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Change in plasma levels of Apolipoprotein A1 (ApoA1)
研究概览
简要总结
The purpose of this study was to assess the effect of the daily intake of yogurts enhanced with Sacha Inchi oil and hybrid palm tree oil on human plasma lipids related to cardiovascular risk factors
详细描述
After being recruited and signing a written informed consent about the study and potential risks, the participants were randomized and assigned in a double-blind manner to one of three intervention groups (control yogurt, sacha inchi oil yogurt, or hybrid palm tree oil yogurt; consumption 1 bottle of 200ml per day for 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Forty-seven subjects were randomized and assigned to one of the three intervention groups supplemented daily with 200g of: Sacha Inchi Oil (SIO)-containing yogurt (Group-A), Hybrid palm oil (HPO)-containing yogurt (Group-B), and plain yogurt (Group-C).
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal total cholesterol (≤200mg/dl) levels
- •Have a yogurt consumption habit of at least three times a week
- •Maximum level of moderate physical activity
- •Body mass index (BMI) of ≤29.9kg/m2
- •Serum triacylglycerols below 400mg/dl
排除标准
- •Presence of chronic disease (Arterial hypertension, Diabetes Mellitus, among others)
- •A history of illicit drug use and/or chronic alcohol use, active smoking
- •A well-established allergy to red palm olein and/or milk and its derivatives
- •Consumption of nutritional supplements (antioxidants, omega 3, fiber, phytosterols)
- •Pregnancy or lactation
- •Having menopause
- •High consumption of nuts, flaxseed, chia, and sesame seeds
结局指标
主要结局
Change in plasma levels of Apolipoprotein A1 (ApoA1)
时间窗: Baseline, 1 month, 2 months and 3 months
Measure in plasma (g/l)
Change in plasma levels of Apolipoprotein B (ApoB)
时间窗: Baseline, 1 month, 2 months and 3 months
Measure in plasma (g/l)
Change in plasma levels of total cholesterol
时间窗: Baseline, 1 month, 2 months and 3 months
Measure in plasma (mmol/l)
Change in plasma levels of LDL-cholesterol
时间窗: Baseline, 1 month, 2 months and 3 months
Measure in plasma (mmol/l)
Change in plasma levels of HDL-cholesterol
时间窗: Baseline, 1 month, 2 months and 3 months
Measure in plasma (mmol/l)
Change in plasma levels of triacylglycerols
时间窗: Baseline, 1 month, 2 months and 3 months
Measure in plasma (mmol/l)
ApoB/ApoA1 ratio
时间窗: Baseline, 1 month, 2 months and 3 months
prognostic predictor of a 10 year cardiovascular event
次要结局
未报告次要终点
研究者
Ruby Alejandra Villamil
Principal investigator
Pontificia Universidad Javeriana