NCT03986775已完成不适用
AFCRO-066: A Double-blinded, Randomized, Controlled, Acute, Cross-over Study to Determine the Efficacy of Palatinose™ Versus Sucrose on Flow Mediated Dilation in Healthy Subjects With Mild Hypertension
Beneo-Institute0 个研究点目标入组 80 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Brachial ultrasound FMD scan
研究概览
简要总结
To determine the efficacy of Palatinose versus sucrose on Flow Mediated Dilation (FMD) in healthy subjects with mild hypertension.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is healthy at the time of pre-examination
- •Subject has a BMI of 25 - 35 kg/m²
- •Subject is aged 25 - 50 years at the time of pre-examination
- •Signed written informed consent
- •Inactive (IPAQ score <1)
- •Waist to Hip ratio ≥0.90 cm for males, ≥0.85 cm for females
- •High-normo/Mild hypertensive (SBP: 130-159 mmHg / DBP: 80-99 mmHg)
排除标准
- •Use of medication interfering with RAAS, such as ACE-inhibitors,
- •Advanced cardio-vascular disease (CVD),
- •Severe kidney disorders (CKD),
- •Diabetes mellitus, both type 1 and II diabetes,
- •Pregnant, lactating or wish to become pregnant,
- •Hypersensitivity to any of the components of the test product,
- •Restricted diet (vegetarian)
- •Thyroid disease
- •Heavy Smokers (light smokers allowed)
- •Lack of suitability for participation in the trial, for any medical reason, as judged by the PI.
- •Excessive alcohol consumption (>21 units/week for males & >14 units/week for females)
研究组 & 干预措施
citrus drink with sucrose
Placebo Comparator
干预措施: sucrose (Dietary Supplement)
citrus drink with isomaltulose
Active Comparator
干预措施: isomaltulose (Dietary Supplement)
结局指标
主要结局
Brachial ultrasound FMD scan
时间窗: Baseline, 60 minutes, 120 minutes, 180 minutes
Changes in postprandial flow-mediated Dilation (endothelial function)
次要结局
- Postprandial glycemic response(Baseline, 60 minutes, 120 minutes, 180 minutes)
- Postprandial insulin response(Baseline, 60 minutes, 120 minutes, 180 minutes)
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