A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers
A Placebo-Controlled, Single-Blind Sequential Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goer
1 other identifier
interventional
36
1 country
2
Brief Summary
The present study is a placebo- controlled, single-blind sequential study. Total of 40 males aged between ≥ 18 years and ≤35 years will be screened. Assuming screen failure and dropout rate in this study, a minimum of 30 participants should complete the study. The treatment duration for all the study participants will be 60 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2023
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
July 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedAugust 24, 2023
August 1, 2023
5 months
June 22, 2023
August 22, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
Day 31
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
Day 61
Secondary Outcomes (7)
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Day 0, Day 31 and Day 61
- +2 more secondary outcomes
Study Arms (2)
EB-PA
ACTIVE COMPARATOROne capsule to be taken after breakfast once a day for 30 days
Placebo
PLACEBO COMPARATOROne capsule to be taken after breakfast once a day for 30 days
Interventions
Eligibility Criteria
You may qualify if:
- Males aged ≥18 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 ≥3 months.
- Habitual non-veg eater
- Body mass index (BMI) 22 - 29.9 kg/ m2
- Waist Circumference 94-102 cm
- Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs before the exercise lab visit.
- Fasting blood Glucose ≤ 125 mg/ dl
- Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg
- TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dr. Kumta Solanki's Clinic
Mumbai, Maharashtra, 400053, India
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, 400607, India
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2023
First Posted
July 3, 2023
Study Start
July 27, 2023
Primary Completion
December 15, 2023
Study Completion
December 15, 2023
Last Updated
August 24, 2023
Record last verified: 2023-08