Study to Evaluate the Efficacy of EB-PA on Muscle Mass & Strength in Occasional Gym Goer
- Registration Number
- CTRI/2023/07/055574
- Lead Sponsor
- Vedic Lifesciences Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Males aged not less than or equal to 18 to not more than equal to 35 years with moderate physical activity levels as per International Physical Activity Questionnaire (IPAQ-SF).
-Occasionally gym goer with a history of at least 1 month of training but not participating in the resistance-type activity for not less than or equal to 3 months. -Habitual non-veg eater.
-Body mass index (BMI) 22 to 29.9 kg per m2.
-Waist Circumference 94 to 102 cm.
-Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs before the exercise lab visit.
-Fasting blood Glucose not more than or equal 125 mg/dl.
-Systolic Blood Pressure not more than or erqal to 129 mm Hg and Diastolic Blood Pressure not more than or equal to 89 mm Hg.
-TSH (thyroid stimulating hormone) less than or equal to 0.4 and more than or equal to 4.9 mIU/L.
-Engaged in structured weight training for more than 12 months before screening.
-Presence of chronic disease
-Changes in body weight of more than 4.5 kg (10 pounds) in the past three months
-Individuals with uncontrolled hypertension
-Known cases of Type II Diabetes mellitus
-History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders
-Individuals who have any other disease or condition or are using any medication that, in the investigator’s judgment would put them at unacceptable risk for participation in the study or may interfere with evaluations or non-compliance with treatment or visits
-Individuals who have been part of a clinical trial within 90 days before the screening.
-Individuals who have used whey or other supplements anytime in the last 3 months
-Individuals who have used whey or other supplements anytime in the last 3 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension & flexion)Timepoint: Day 0, Day 31 & Day 61
- Secondary Outcome Measures
Name Time Method