Clinical trial NCT05002881: A Study to Explore the Effect of Moringa Oleifera (E-HS-01) on Flow Mediated Dilatation and Hemodynamics
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endothelial Function
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-08-12
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, Double-blind, Cross-over, Placebo controlled study
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent flow mediated dilatation
timeFrame: From baseline (pre-IP administration) to 3 hours post-IP administration
Secondary outcomes:
measure: Blood flow velocity
timeFrame: at baseline (pre-IP administration) and at 1, 2, and 3 hours post-IP administration
measure: Percent flow mediated dilatation
timeFrame: at 1, and 2 hours post-IP administration from baseline (pre-IP administration)
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Vedic Lifesciences
state: Maharashtra
Study officials:
affiliation: Vedic lifesciences
name: Dr, Anjali Jain, BHMS
role: PRINCIPAL_INVESTIGATOR
References: