Last updated: February 21, 2022
Sponsor: Vedic Lifesciences Pvt. Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aneurysm
Treatment
N/AClinical Study ID
NCT05002881
EB/210502/MO/FMD
Ages 20-35 Male Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Healthy, physically active male volunteers aged between 20 to 35 years.
- Body mass index (BMI) ≥ 20 and ≤ 29.9 kg/m2.
- Participants with low to moderate physical activity as defined by a six-point scalescore of ≥1 to ≤ 4.
- 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 toparticipate in the study.
- Ready to abstain from alcohol, caffeine, and vigorous physical activity (as assessedby 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 everystudy visit.
Exclusion
Exclusion Criteria:
- Participants with history of pulmonary disorders (asthma, chronic obstructivepulmonary 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 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). - 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 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
IndiaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.