The Effect of Citric Flavonoid Administration on Endothelial Function and Gut Barrier Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Endothelial function
研究概览
简要总结
This randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh subjects.
Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum levels of specific metabolites of the study product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, 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
- •Overweight men/women (BMI 25-35 kg/m2)
- •Healthy individuals
- •Age between 18 and 70 years
- •Fasting glucose < 7.0 mmol/L
- •Normal HbA1c (4.4 to 6.2%)
排除标准
- •Type 2 diabetes mellitus (defined as fasting plasma glucose ≥ 7.0 mmol/L)
- •Gastroenterological diseases or abdominal surgery
- •Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
- •Self-admitted HIV-positive status
- •Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
- •Plans to lose weight or following a hypocaloric diet during the study period
- •Weight gain or loss > 3 kg in previous 3 months
- •Use of medication interfering with endpoints
- •Intake of antihypertensive medication, statins, corticosteroids, NSAIDs, ciclosporin A, rifampicin are strictly forbidden
- •Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
- •Hormone replacement therapy (women)
- •Use of antibiotics in the 90 days prior to the start of study
- •Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
- •Known pregnancy (assessed by a pregnancy test before start of study), lactation
- •Blood donation within 3 months before study period
- •Failure to comply prohibited intake of hesperidin containing food products during study period and prohibited intake of food products that are able to influence the FMD measurements one day prior to test days.
- •History of any side effects towards the intake of flavonoids or citrus fruits
结局指标
主要结局
Endothelial function
时间窗: 6 weeks
The primary objective of this study is to evaluate the efficacy on endothelial function, as assessed by flow mediated dilatation (FMD) measurements, after 6 weeks of administration of study product.
次要结局
- Glucose / insulin metabolism(6 weeks)
- Endothelial function(6 weeks)
- Blood pressure & heart rate(6 weeks)
- Colonic inflammation(6 weeks)
- Bioavailability and metabolism(5 days)
- Lipid profile(6 weeks)
- Gut barrier function(6 weeks)
研究者
Bouke Salden
Coordinating Investigator
Maastricht University Medical Center