None listed
Conditions
Interventions
Intervention1: BeepActive 500mg: Oral Administration of 500 mg capsule once a day for 7 days
Intervention2: BeepActive 1000mg: Oral Administration of 1000 mg capsule once a day for 7 days
Control Inte
Sponsors
Samriddh Nutractive Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy, physically active subjects. 2. Body mass index (BMI) = 20 and = 29.9 kg/m2. 3. Subjects with systolic blood pressure (SBP) = 139 and diastolic blood pressure (DBP) = 89 mm Hg. 4. Subjects willing to abstain from alcohol, caffeine, and vigorous physical activity for 24 hours prior to every study visit. 5. Subjects who agree to have at least 8-hour sleep before the visit days and during the study period. 6. Female subjects of child bearing potential practicing an acceptable method of birth control. 7. Subjects willing to provide written consent. 8. Subjects willing to abstain from moringa, spinach or other ingredients known to increase vasodilation for 48 hours prior to every study visit. 9. Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
Exclusion criteria
Exclusion criteria: 1.Subjects having hypersensitivity or history of allergy to the study product. 2.Subjects with history of pulmonary disorders [asthma, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pneumonia, etc]. 3.Subjects having fasting blood glucose (FBG) levels = 125 mg/dL. 4.Subjects currently on/or having history of taking antihypertensives / diuretics. 5.Subjects who are currently on performance enhancing supplements. 6.Smokers and tobacco users. 7.Subjects with sleep disturbances and/or are taking sleep aid medication 8.Subjects with uncontrolled hypertension (systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg) at screening. 9.Subjects with any chronic conditions which in the opinion of investigator may interfere with the study outcomes. 10.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period. 11.Subjects with positive Urine Pregnancy Test at Screening /Randomization Visit. 12.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline for BeepActive 500 mg and 1000 mg compared to placebo on flow mediated dilatation from brachial artery.Timepoint: Day 1: Baseline, Post-Dose - 1 hour, 2 hour Day 7: Baseline, Post-Dose - 1 hour, 2 hour | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline for BeepActive 500 mg and 1000 mg compared to placebo on blood flow velocityTimepoint: Baseline to 1-, and 2-hours post-dose on day 1 and day 7;Mean change from baseline for BeepActive 500 mg and 1000 mg compared to placebo on brachial artery diameterTimepoint: Baseline to 1-, and 2-hours post-dose on day 1 and day 7;Mean change from baseline in fatigue scale scoresTimepoint: Baseline to Day 7;Safety of the study productsTimepoint: Baseline to day 7 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt.Ltd.
Outcome results
None listed