Clinical trial NCT05926609: A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers
Official title: A Placebo-Controlled, Single-Blind Sequential Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Mass and Strength
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Single-blind, placebo - controlled trial
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
timeFrame: Day 31
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
timeFrame: Day 61
Secondary outcomes:
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
timeFrame: Day 0, Day 31 and Day 61
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
timeFrame: Day 0, Day 31 and Day 61
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
timeFrame: Day 0, Day 31 and Day 61
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
timeFrame: Day 0, Day 31 and Day 61
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
timeFrame: Day 0, Day 31 and Day 61
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
timeFrame: Day 0, Day 31 and Day 61
measure: To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
timeFrame: Day 0, Day 31 and Day 61
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Dr. Kumta Solanki's Clinic
state: Maharashtra
city: Thane
country: India
facility: Dr. Preeti Bawaskar's Clinic
state: Maharashtra
Study officials:
References: