A Randomized, Double-blind, Cross-over, Placebo Controlled Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percent flow mediated dilatation
研究概览
简要总结
The present study is designed to evaluate the modulatory effect of IP on the vascular endothelial function. To assess its vasodilatation potential, change in flow mediated dilation (FMD) and blood flow velocity (BFV) will be assessed in healthy adult male population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind, Cross-over
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, physically active male volunteers aged between 20 to 35 years.
- •Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m
- •Participants with low to moderate physical activity as defined by a six-point scale score of ≥1 to ≤
- •Participants with systolic blood pressure (SBP) ≤ 139 and diastolic blood pressure (DBP) ≤ 89 mm Hg.
- •Ability to read and provide written, personally signed, and dated informed consent to participate in the study.
- •Ready to abstain from alcohol, caffeine, and vigorous physical activity (as assessed by six point scale) for 24 hours prior to every study visit.
- •Ready to abstain from beet root, moringa, and spinach for 48 hours prior to every study visit.
排除标准
- •Participants with history of pulmonary disorders (asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pneumonia, etc)
- •Participants having fasting blood glucose (FBG) levels ≥ 125 mg/dL.
- •Participants currently on/or having history of taking antihypertensives / diuretics.
- •Smokers and tobacco users.
- •Participants with heavy alcohol consumption, defined as more than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
- •(NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
- •Participants currently on performance enhancing supplements.
- •History/symptoms of coronary artery disease, myocardial infarction etc.
- •Participants with any other condition which in the view of the investigator is likely to interfere with the study or put the participants at risk.
研究组 & 干预措施
Moringa oleifera (E-HS-01)
One capsule to be taken stat
干预措施: Moringa oleifera (E-HS-01) (Other)
Moringa oleifera (E-HS-01)
One capsule to be taken stat
干预措施: Placebo (Other)
Placebo
One capsule to be taken stat
干预措施: Moringa oleifera (E-HS-01) (Other)
Placebo
One capsule to be taken stat
干预措施: Placebo (Other)
结局指标
主要结局
Percent flow mediated dilatation
时间窗: From baseline (pre-IP administration) to 3 hours post-IP administration
To determine change in the endothelial function after single dose administration of Moringa oleifera as assessed by the change in the Percent flow mediated dilatation of brachial artery, from baseline (pre-IP administration) to 3 hours post IP administration, in comparison to the placebo.
次要结局
- Blood flow velocity(at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration)
- Percent flow mediated dilatation(at 1, and 2 hours post-IP administration from baseline (pre-IP administration))