None listed
Conditions
Interventions
Intervention1: EB-PA: One capsule is to be taken after breakfast Once a day for 60 days
Control Intervention1: Microcrystalline Cellulose: One capsule is to be taken after breakfast Once a day for 60
Sponsors
Vedic Lifesciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP)on Improvement in metabolic health as indicated by the waist-to-height ratio (WHtR)Timepoint: Day 0, Day 31 & Day 61;To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on Decrease in central obesity as indicated by a decrease in android fat percentage by DXATimepoint: Day 0, Day 31 & Day 61;To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on Improvement in muscle mass as indicated by an increase in fat-free mass (FFM) by DXA.Timepoint: Day 0, Day 31 & Day 61;To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on Improvement in upper body strength as assessed by medicine ball throw testTimepoint: Day 0, Day 31 & Day 61;To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on Improves muscle protein synthesis as assessed by an increase in serum insulin at 0, 1 & 3 hours post IP administrationTimepoint: Day 0, Day 31 & Day 61;To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on Increase in the lower-body strength (Peak anaerobic power output (PAPw)) as assessed by a vertical jump testTimepoint: Day 0, Day 31 & Day 61;To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on The flexibility of the hamstrings as assessed using the V sit-and-reach testTimepoint: Day 0, Day 31 & Day 61 | — |
Countries
India
Contacts
Public ContactDr Sonali Ghosh
Vedic Lifesciences
Outcome results
None listed