None listed
Conditions
Interventions
Intervention1: BeepActive: One BeepActive capsule once a day for 28 days
Control Intervention1: Placebo: One Placebo capsule once a day for 28 days
Sponsors
Samriddh Nutractive Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects must have a BMI of 18.5 to 29.9 kg/m (both limits inclusive).2.Subjects who are physically active and healthy athletes.3. Subjects who are not taking any supplements with anabolic agents (muscle building) and/or protein powder in the past 4 weeks.4.Subjects must be free of any physical limitations or chronic illness that may affect performance.5.Subjects must be free of any medications.6.Subjects who agree to refrain from consuming alcohol 24 hours prior to the visit days.7.Subjects who agreed to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days.8.Subject willing to provide written consent.9.Subjects willing to refrain from vigorous physical activity/ strenuous exercise 24 hours prior to test days.10.Subjects 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 uncontrolled hypertension (SBP greater than 160 mmHg or DBP less than 100 mmHg) at screening. 3.Subjects currently on any medication 4.Subjects with a malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection. 5.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease or from a disease found to be inconsistent with the conduct of the study by the investigator.6.Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.7.Subjects with a history of drug and /or alcohol abuse at the time of enrolment.8.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 in 1-RM muscle strength including Quadriceps strength, and Pectoral strength assessed by leg press and bench press exercises in the following efficacy parameters assessed for BeepActive compared to placebo. Timepoint: Day 1, Day 28, Day 42 and Day 70 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in hand grip strength assessed by hand held dynamometerTimepoint: Day 1, Day 28, Day 42 and Day 70;Change in walking distance, nitric oxide and muscle oxygenationTimepoint: Day 1, Day 28, Day 42 and Day 70;Change in rate of perceived exertionTimepoint: Day 1, Day 28, Day 42 and Day 70;Change in body composition parameters assessed by DEXATimepoint: Day 1, Day 28, Day 42 and Day 70 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed