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

Last updated: February 21, 2022
Sponsor: Vedic Lifesciences Pvt. Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Treatment

N/A

Clinical Study ID

NCT05002881
EB/210502/MO/FMD
  • Ages 20-35
  • Male
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Healthy, physically active male volunteers aged between 20 to 35 years.
  2. Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
  3. Participants with low to moderate physical activity as defined by a six-point scalescore of ≥1 to ≤ 4.
  4. Participants with systolic blood pressure (SBP) ≤ 139 and diastolic blood pressure (DBP) ≤ 89 mm Hg.
  5. Ability to read and provide written, personally signed, and dated informed consent toparticipate in the study.
  6. Ready to abstain from alcohol, caffeine, and vigorous physical activity (as assessedby six point scale) for 24 hours prior to every study visit.
  7. Ready to abstain from beet root, moringa, and spinach for 48 hours prior to everystudy visit.

Exclusion

Exclusion Criteria:

  1. Participants with history of pulmonary disorders (asthma, chronic obstructivepulmonary disease (COPD), pulmonary fibrosis, pneumonia, etc)
  2. Participants having fasting blood glucose (FBG) levels ≥ 125 mg/dL.
  3. Participants currently on/or having history of taking antihypertensives / diuretics.
  4. Smokers and tobacco users.
  5. Participants with heavy alcohol consumption, defined as more than 14 standardalcoholic drink (SAD)/week or more than 4 SAD in a day. (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, whichis 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., sherryor port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
  6. Participants currently on performance enhancing supplements.
  7. History/symptoms of coronary artery disease, myocardial infarction etc.
  8. Participants with any other condition which in the view of the investigator is likelyto interfere with the study or put the participants at risk.

Study Design

Total Participants: 60
Study Start date:
August 16, 2021
Estimated Completion Date:
March 31, 2022

Connect with a study center

  • Vedic Lifesciences

    Mumbai, Maharashtra 400053
    India

    Active - Recruiting

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