Status:
RECRUITING
A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
Lead Sponsor:
Vedic Lifesciences Pvt. Ltd.
Conditions:
Skeletal Muscle Strength & Growth
Eligibility:
MALE
20-35 years
Phase:
NA
Brief Summary
The present study is a randomized, placebo-controlled, double blinded study to evaluate efficacy of EB-PA as protein amplifier for skeletal muscle strength \& growth in males with active lifestyle. Ap...
Eligibility Criteria
Inclusion
- Males aged 20 - 35 years with active lifestyle with moderate physical activity level as per International Physical Activity Questionnaire.
- Recreationally gym goer with history of at least 1 month of endurance training (E.g.: functional exercises)
- Not participating in resistance type training (E.g.: external or body weight training) for ≥3 months prior to screening.
- Body mass index (BMI) 22 - 29.9 kg/ m2.
- Individuals with a 1-RM strength defined by Upper Body ≥ 25 Kgs and Lower Body ≥ 100 Kgs will be included in the study.
- Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs prior to the exercise lab visit.
- Fasting Blood Glucose ≤ 110 mg/ dl.
- Systolic Blood Pressure ≤ 129 mmHg and Diastolic Blood Pressure ≤ 89 mmHg.
- TSH (thyroid stimulating hormone) ≥ 0.4 and ≤ 4.9 mIU/L.
Exclusion
- Engaged in structured weight training for more than 3 months prior to screening.
- Presence of chronic disease.
- Changes in body weight more than 4.5 kg (10 pounds) in the past three months as assessed by history.
- Subjects diagnosed with hypertension.
- Subjects who are diagnosed with Type I Diabetes Mellitus and Type II Diabetes Mellitus.
- History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic or neurologic disorders.
- Allergy to whey protein or herbal ingredients.
- Subjects who have any other disease or condition, or are using any medication, that in the judgment of the investigator would put them at unacceptable risk for participation in the study or may interfere with evaluations in the study or noncompliance with treatment or visits.
- Subjects who have been part of a clinical study within 90 days prior to the screening.
- Subjects who have used whey or other supplemental proteins anytime in last 3 months.
Key Trial Info
Start Date :
November 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2024
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06127849
Start Date
November 28 2023
End Date
June 5 2024
Last Update
February 1 2024
Active Locations (3)
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1
Dr. Khare's Clinic
Mumbai, Maharashtra, India, 400053
2
Nirmala Clinic
Mumbai, Maharashtra, India, 400101
3
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, India, 400607