Clinical trial NCT06127849: A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
Official title: A Randomized, Placebo-controlled, Blinded Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skeletal Muscle Strength & Growth
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-13
Enrollment: 138
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled, double-blinded study
Primary purpose: OTHER

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. Approximately 160 subjects aged between ≥ 20 and ≤ 35 years will be screened and 138 participants are to be randomized. Both the IP and placebo study arms will have at least 40 completed subjects after accounting for the screening failure and dropout/withdrawal rate of 14% and 13 % respectively (Total 120 completers). The treatment duration for all the study subjects will be 30 days. The sustained effect of the product will be observed for next 7 days, wherein, the subjects will be abstaining from the protein and IP supplementation and will exercise at their ease.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in lower body 1 RM (repetition maximum) weight from baseline.
timeFrame: Day 30
measure: To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in upper body 1 RM (repetition maximum) weight from baseline.
timeFrame: Day 30
Secondary outcomes:
measure: To assess the effect of Investigational Product (IP) on Increase in muscle endurance as assessed by increase in exercise volume calculated as load x number of repetition (upper + lower body exercise) completed at ≥70% of screening 1-RM.
timeFrame: Day 0 to Day 30
measure: To assess the effect of Investigational Product (IP) on Increase in muscle (hamstring) flexibility as assessed by increase in distance for V sit & reach test.
timeFrame: Day 0 to Day 30
measure: To assess the effect of IP on improvement in muscle mass as indicated by increase in fat free mass (FFM), lean muscle mass and android fat by DXA.
timeFrame: Day 0 to Day 30
measure: To assess the effect of IP on improvement in grip strength as indicated by increase in non-dominant hand grip strength.
timeFrame: Day 0 to Day 30
measure: To assess the effect of IP on Improvement in metabolic health as indicated by waist to height ratio.
timeFrame: Day 0 to Day 30
measure: To assess the sustained effect of IP on muscle strength as assessed by Maintenance of lower body 1 RM weight
timeFrame: Day 30 To 37
measure: To assess the sustained effect of IP on muscle strength as assessed by Maintenance of upper body 1RM weight
timeFrame: Day 30 To 37
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Dr. Khare's Clinic
state: Maharashtra
city: Mumbai
country: India
facility: Nirmala Clinic
state: Maharashtra
city: Thane
country: India
facility: Dr. Preeti Bawaskar's Clinic
state: Maharashtra
Study officials:
References: