The Effect of an Apple Polyphenol Extract Rich in Epicatechin and Flavan-3-ol Oligomers (Evesse™ EPC) on Brachial Artery Flow-mediated Vasodilatory Function (FMD)in Volunteer Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Brachial flow-mediated dilation test (FMD)
研究概览
简要总结
Effect of apple polyphenols on FMD.
详细描述
The aim of this single centre, repeated-dose, double-blind, placebo-controlled, crossover study is to test the hypothesis that an orally ingested apple polyphenol extract rich in epicatechin and flavan-3-ol oligomers improves brachial artery endothelium-dependent vasodilation function (FMD) in volunteer subjects with borderline hypertension. FMD and endothelium-independent nitrate-mediated vasodilatation (NMD) of the left brachial artery will be investigated with ultrasonography at the start and end of both treatment periods. Biomarkers of vascular function and epicatechin (and metabolite) concentrations will be determined from blood samples taken at the start and end of both treatment periods. Diet diary data will be collected for the evaluation of the possible effects of diet on the study results. Adverse events data will be collected throughout the study. Safety laboratory determinations will be performed at the last visit of both treatment periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Borderline hypertension
- •Otherwise healthy
- •Aged 40-65 years (inclusive)
- •Not consuming high amounts (over 20 mg daily) of flavonoids
排除标准
- •BMI >32 kg/m2
- •Total serum cholesterol ≥ 8 mmol/l
- •Any abnormal safety laboratory parameter or abnormal finding in ECG evaluated to be clinically significant
- •Coronary artery disease
- •Pregnancy or lactating
- •Alcohol abuse as evaluated by medical history
- •Regular smoking/using nicotine products
- •Diabetes mellitus
- •Apple allergy
- •Use of lipid lowering medications
- •Regular use of any medication that is known or believed to affect endothelial function or blood vessel constriction
- •Any other condition or medication that in the opinion of the investigator would interfere with the evaluation of the study results or constitute a health risk for the subject
- •High consumption of vitamin products, herbal remedies or products containing flavonoids
研究组 & 干预措施
Microcrystalline cellulose
The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods.
干预措施: Microcrystalline cellulose (Dietary Supplement)
Epicatechin
The subjects will receive the study product and corresponding placebo once a day for 4 weeks in randomised order. There will be a four to five-weeks wash-out between the treatment periods.
干预措施: Epicatechin (Dietary Supplement)
结局指标
主要结局
Brachial flow-mediated dilation test (FMD)
时间窗: At first visits of both periods baseline FMD will be recorded followed by FMD recording 1.5 hours after first dose. After 4 weeks intervention, at last visits of both periods FMD will be recorded, last dose will be taken and FMD recorded 1.5 hours after.
ultrasonography, FMDmax%
次要结局
- Nitrate-mediated vasodilatation response (NMD)(At the first and last visits of both periods, approximately 10 minutes after FMD.)
- Circulating biomarkers of vascular function(Once at the first visit of both periods and once at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter)
- BP(Once at the first visit of both periods and once at the last visit of both periods. Blood pressure will be recorded twice prior to the morning dose.)
- Plasma epicatechin concentration(At the first visit of both periods and at the last visit of both periods. Blood sampling prior to the morning dose and appr. 2 h thereafter)