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

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

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 Overview

• Status: Recruiting
• Conditions: Endothelial Function
• Intervention / Treatment: Other: Moringa oleifera (E-HS-01); Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Shalini Dr. Srivastava, MD - Medicine; Phone Number: 326 022 42172326; Email: shalini.s@vediclifesciences.com
• Study Contact Backup: Name: Mr. Zubair Ansari, M pharm; Phone Number: 7738945639; Email: zubair@vediclifesciences.com

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 400053
      • Recruiting
      • Vedic Lifesciences
      • Contact: Dr. Anjali Jain, BHMS
      • Contact: zubair Ansari, Mpharm; Phone Number: 7738945639; Email: zubair@vediclifesciences.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 scale score 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 to participate in the study.
6. Ready to abstain from alcohol, caffeine, and vigorous physical activity (as assessed by 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 every study visit.

Exclusion Criteria:

1. Participants with history of pulmonary disorders (asthma, chronic obstructive pulmonary 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 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).

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 likely to interfere with the study or put the participants at risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Investigators: Principal Investigator: Dr, Anjali Jain, BHMS, Vedic Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: EB/210502/MO/FMD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No