Study of the Effects of Yerba Mate on Cardiometabolic Health
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
- 2
- 主要终点
- Blood lipids
研究概览
简要总结
The goal of this clinical trial is to learn if consuming a beverage prepared with yerba mate leaves helps to improve blood lipid levels in persons at high cardiovascular risk. It will also learn about the effects of this beverage, widely consumed in South America, on other cardiometabolic biomarkers like blood glucose levels, inflammation, or weight control. The main questions it aims to answer are:
Does daily consumption of a yerba mate tea reduce the blood lipid levels in hypercholesterolemic persons? May healthy persons also benefit from the consumption of yerba mate tea?
Researchers will compare yerba mate to a control drink (isotonic drink or water, free of polyphenols and caffeine) to see if yerba mate tea helps to reduce blood cholesterol in hypercholesterolemic persons.
Participants will:
Drink 3 cups of yerba mate tea or an isotonic drink every day for 2 months, then change to the other drink during another 2 months.
Visit the clinic at the beginning and end of each 2-month period for checkups and tests Refraing from consuming coffee and some foods during the study. Complete a dietary questionnaire during 3 days before each visit to the clinic.
详细描述
This is a randomized, crossover, control study in healthy and hypercholesterolemic free-living to assess the effect of yerba mate on different outcomes related to cardiovascular health.
After a 2-week run-in period, participants will be randomly allocated to the first 8-weeks intervention with yerba mate or the control drink. After a 3-week wash-out, they will change to consume during 8 weeks the other drink.
A nurse will collect a fasting blood sample at the beginning and end of each intervention stage. Blood pressure and anthropometric parameters will be measured. A 72-h dietary record will be completed by participants before each visit to the Human Nutrition Unit (HNU) at the Institute of Food Science, Technology and Nutrition (ICTAN-CSIC).
During the study, participants will refrain from consuming coffee, cocoa, tea, and caffeine-containing drinks. Other foods rich in certain polyphenols (i.e. hydroxycinnamic acids) will also be restricted.
Blood samples will be used to measure different biomarkers of relevance in cardiometabolic health, as listed in the Outcomes section.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 20-25 kg/m2
- •Total cholesterol < 200 mg/dL for healthy participants, between 200-240 mg/dL for participants at cardiovascular risk, or
- •LDL cholesterol < 130 mg/dL for healthy participants, between 130-159 mg/dL for participants at cardiovascular risk.
排除标准
- •Pregnant/lactating women
- •Vegetarians/vegans
- •Consumption of vitamins or dietary supplements
- •Suffering from chronic diseases/pathologies/conditions appart from hypercholesterolemia
- •On prescription drugs (statins) or on antibiotics 6 months before the study
结局指标
主要结局
Blood lipids
时间窗: From enrollment to the end of each treatment at 8 weeks
Change in blood levels of total cholesterol or LDL-cholesterol or VLDL-cholesterol or HDL-cholesterol or triglycerides or phospholipids at the end of the intervention with yerba mate
次要结局
- Blood pressure(From enrollment to the end of each treatment at 8 weeks)
- Inflammatory cytokines(From enrollment to the end of each treatment at 8 weeks)
- Fasting blood glucose(From enrollment to the end of each treatment at 8 weeks)
- Fasting blood insulin(From enrollment to the end of each treatment at 8 weeks)
- Insulin resistance(From enrollment to the end of each treatment at 8 weeks)
- Insulin sensitivity(From enrollment to the end of each treatment at 8 weeks)
- Hormones, incretins and adipokines levels(From enrollment to the end of each treatment at 8 weeks)
- Cytokines, chemokines and cell-adherence molecules levels(From enrollment to the end of each treatment at 8 weeks)
- Liver function(From enrollment to the end of each treatment at 8 weeks)
- Anthropometry(From enrollment to the end of each treatment at 8 weeks)