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

Vedic Lifesciences

Status: Unknown

Conditions: Endothelial Function

Treatments: Other: Moringa oleifera (E-HS-01); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05002881

EB/210502/MO/FMD

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Moringa oleifera (E-HS-01)

Active Comparator group

Description:

One capsule to be taken stat

Treatment:

Other: Placebo

Other: Moringa oleifera (E-HS-01)

Placebo

Placebo Comparator group

Description:

One capsule to be taken stat

Treatment:

Other: Placebo

Other: Moringa oleifera (E-HS-01)