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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percent flow mediated dilatation
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind, Cross-over
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
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.
Arms & Interventions
Moringa oleifera (E-HS-01)
One capsule to be taken stat
Intervention: Moringa oleifera (E-HS-01) (Other)
Moringa oleifera (E-HS-01)
One capsule to be taken stat
Intervention: Placebo (Other)
Placebo
One capsule to be taken stat
Intervention: Moringa oleifera (E-HS-01) (Other)
Placebo
One capsule to be taken stat
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Percent flow mediated dilatation
Time Frame: 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.
Secondary Outcomes
- 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))