The Effects of Onion on Plasma Lipoproteins, Blood Pressure and Gene Expression in Overweight Humans - a Double-blinded, Randomized Cross-over Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in blood pressure from baseline to two weeks
研究概览
简要总结
AIMS:
The aims are to investigate whether:
- Increased intake of onion (powder) affects plasma lipid profile, blood pressure, indices of insulin sensitivity and blood coagulation.
- Increased intake of onion (powder) affects the expression/activity of enzymes in the defence against foreign substances, e.g. reactive oxygen species, and whether polymorphisms in some of the involved genes may modulate the effect.
- Polymorphisms involved in the metabolism/effect of bioactive components in onion modulate the excretion of metabolites or modulate some of the outcome variables in the study.
Other aims are to try to identify biomarkers for onion consumption in plasma, urine and feces and to investigate whether onion affects the secretion of fat and bile acids.
HYPOTHESES:
The investigators hypothesize that:
- 2 weeks of increased onion intake will improve the plasma lipid profile
- 2 weeks of increased onion intake will increase the metabolism of potentially harmful substances (such as ROS and free radicals) through a change in the expression or activity of certain enzymes.
- That these effects are modulated by common gene variants (polymorphisms)
详细描述
In a randomized controlled crossover design, participants will receive 2 daily meals with or without onion powder for 2 weeks. Between the two 2-week period is a 4-week wash-out period. One week before and during each intervention period, the participants will be instructed to avoid consumption of onion, garlic and all foodstuffs containing the same bioactive components (polyphenols, sulfur-molecules)as in onion. This includes a number of vegetables and fruits, condiments, tea, chocolate, red wine etc.
Fasting blood samples will be drawn before and after (on 2 separate days) each intervention period, where also weight and blood pressure are measured.
Participants will collect 24-hour urine and feces samples twice before and at completion of each intervention period.
After the fasting blood sampling on the first blood sampling day in each period, participants will receive a test meal (with 10 g onion powder or placebo, i.e. 8.5 g sucrose+ 2 g soy protein isolate). The acute effects will be studied by blood sampling and urine sampling 0, 2, 4 and 24 hours after the test meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 25-40
- •No daily medication (except thyroid hormone, stomach acid lowering drugs, mild blood pressure lowering drugs and anti-depressants)
- •Not strenuous exercise >10 hours/week
- •No blood donation 3 months before or during the study
排除标准
- •Diabetes, CVD, hepatitis, HIV/AIDS
- •Cancer or cancer treatment within last 6 months
- •Simultaneous participation in other research projects
研究组 & 干预措施
Onion powder
Initial test meal contained 20g freeze dried onion powder in hot meals (1 potato soup and 1 meatball-meal daily). Subsequent daily meals contained 20g onion powder in the same meal formats.
干预措施: Onion powder (Dietary Supplement)
Placebo
Hot meals (1 potato soup and 1 meatball-meal daily)containing 8.5 g sucrose and 2 g soy protein instead of onion powder
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in blood pressure from baseline to two weeks
时间窗: baseline to two weeks
Measured by a standard arm cuff by a trained bioanalyst
次要结局
- Change in waist-to-hip circumference ratio(Change from baseline to two weeks)
- Change in plasma insulin (multivariate ANOVA)(0-14 days)
- Change in plasma glucose (multivariate ANOVA)(0-14 days)
- Change in HOMA(0-14 days)
- Change in ISI240 (Matsuda insulin sensitivity index 0-240)(0-240 minutes)
- Change in erythrocyte Glutathione Reductase(0-2 weeks)
- Change in fecal microbiota profile(change from baseline to two weeks)
- Change in total cholesterol(change from baseline to 2, 4, and 24 hours and 2 weeks)
- Change in HDL cholesterol(change from baseline to 2, 4, and 24 hours and 2 weeks)
- Change in urine metabolomic profiles(0-14 days)
- Change in plasma triacylglycerides(change from baseline to 2, 4, and 24 hours and 2 weeks)
- Change in blood coagulation parameters(0-4 hours)
- Change in whole-blood hematocrit(0-14 days)
- Change in whole-blood haemoglobin concentration(0-14 days)
- Change in urine pH(0-14 days)
- Change in body weight(0-14 days)
- Change in serum VCAM-1(0-14 days)
- Change in serum IL-6(0-14 days)
- Change in serum TNF-alpha(0-14 days)
- Change in faecal metabolic profiles(0-14 days)
- Change in faecal pH(0-14 days)
- Change in faecal bile acids(0-14 days)
- Change in erythrocyte superoxide dismutase(0-2 weeks)
- Change in erythrocyte catalase(0-2 weeks)
- Change in erythrocyte glutathione peroxidase(0-2 weeks)
- Change in plasma untargeted metabolic profile(0-2 weeks)
- Change from baseline in leucocyte gene expression profile(0, 2, 4 and 24 hours and 2 weeks)
研究者
Professor Lars Ove Dragsted
Professor
University of Copenhagen