A Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Endothelial Function

Intervention / Treatment
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* Other: Moringa oleifera (E-HS-01)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, physically active male volunteers aged between 20 to 35 years. Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2. Participants with low to moderate physical activity as defined by a six-point scale score of ≥1 to ≤ 4. 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, Double-blind, Cross-over, Placebo controlled study
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moringa oleifera (E-HS-01)<br>One capsule to be taken stat | Other: Moringa oleifera (E-HS-01)<br>* One capsule to be taken stat<br>Other: Placebo<br>* One capsule to be taken stat<br>|
| Placebo Comparator: Placebo<br>One capsule to be taken stat | Other: Moringa oleifera (E-HS-01)<br>* One capsule to be taken stat<br>Other: Placebo<br>* One capsule to be taken stat<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent flow mediated dilatation | 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. | From baseline (pre-IP administration) to 3 hours post-IP administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood flow velocity | The endothelial function can be assessed by measuring changes in blood flow by intravascular ultrasound. It has been demonstrated that biophysical forces such as flow-derived forces, modulates the vascular structure and function. Endothelium is mechanotransducer, which senses mechanical forces on its surface and the transduces these signals into biochemical signals. There exists a large body of literature regarding the wide spectra of biological signals induced by blood flow in the endothelium.18 Thus to evaluate the effect of Moringa oleifera on hemodynamics, change in blood flow velocity (cm/seconds) will be assessed at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration will be measured. | at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration | 
| Percent flow mediated dilatation | To identify the onset of effect of the investigational product, the flow mediated dilation at 1, and 2 hours post-IP administration from baseline (pre-IP administration) will be assessed as a secondary outcome. | at 1, and 2 hours post-IP administration from baseline (pre-IP administration) |