Olive Polyphenols in Cardiovascular Prevention: Efficacy and Tolerability of a Commercially Available Standardized Olive Extract (Tensiofytol®) as Compared to Placebo in Patients With Elevated Blood Pressure: a RDBPC Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Nina Hermans
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change from baseline Blood Pressure, Systolic at 8 weeks
研究概览
简要总结
The aim of this study is to evaluate whether the use of a commercially available standardized olive extract (Tensiofytol®) in individuals with elevated blood pressure
- Leads to a clinically relevant reduction of blood pressure on the short term,
- Leads to a clinically relevant reduction of cholesterol levels, especially LDL,
- Leads to a change in oxidative stress biomarkers.
Participants will be stratified by sex before randomization to one of the three treatments for 8 weeks:
- Tensiofytol: 100 mg oleuropein and 20 mg hydroxytyrosol per day
- Placebo
All treatments have an identical shape and color and should be used in the same way (oral intake; 3 capsules/day during dinner). No dietary instructions are given and participants are asked not to change their dietary habits, nor to start other therapies (medication, supplements, slimming diets, extra physical activity, etc.) during their study period. Standardized questionnaires are used to obtain information on demographics, dietary habits and side effects. At baseline and after 8 weeks, 27 ml blood is drawn for various biological analyses, and blood pressure, BMI and waist circumference are measured.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic blood pressure ≥ 130 mmHg
排除标准
- •<18 jaar
- •>76 jaar
- •Use of nutritional supplements or (chronic) medication*
- •Triglycerides > 400 mg/dL
- •> 14 alcoholic consumptions/week
- •Chronic illness (e.g. diabetes, atherosclerosis, reumatoid arthritis)
- •Acute infection
- •Current pregnancy or pregnancy wish during the study period
- •Breast feeding
- •When nutritional supplements were used regularly, participation is allowed after a 10-day wash out period.
- •Use of medication will be individually assessed and is permitted if it does not interfere with the used treatments and the patient is stable on the medication.
结局指标
主要结局
Change from baseline Blood Pressure, Systolic at 8 weeks
时间窗: Baseline, 8 weeks
average of 3 measurements during 15 minutes
次要结局
- Change from baseline Blood Pressure, systolic at 4 weeks(Baseline, 4 weeks)
- Change from baseline OxLDL level at 8 weeks(Baseline, 8 weeks)
- Change from baseline HDL cholesterol level at 8 weeks(Baseline, 8 weeks)
- Change from baseline total cholesterol level at 8 weeks(Baseline, 8 weeks)
- Change from baseline triglycerides level at 8 weeks(Baseline, 8 weeks)
- Change from baseline gluathion (GSH) level at 8 weeks(Baseline, 8 weeks)
- Frequency of side effects (+ their burden) as reported in the final questionnaire(8 weeks)
- Change from baseline LDL cholesterol level at 8 weeks(Baseline, 8 weeks)
- Change from baseline Apo A1 level at 8 weeks(Baseline, 8 weeks)
- Change from baseline Apo B level at 8 weeks(Baseline, 8 weeks)
- Change from baseline malondialdehyde (MDA) level at 8 weeks(Baseline, 8 weeks)
- Change from baseline Blood Pressure, diastolic at 8 weeks(Baseline, 8 weeks)
- Change from baseline non-HDL cholesterol level at 8 weeks(Baseline, 8 weeks)
- Change from baseline lipoprotein A (LP(a)) level at 8 weeks(Baseline, 8 weeks)
- Change from baseline Remnant Cholesterol at 8 weeks(Baseline, 8 weeks)