A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers

Vedic Lifesciences

Status: Enrolling

Conditions: Muscle Mass and Strength

Treatments: Dietary Supplement: EB-PA; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05926609

EB/230201/EB-PA/MMS

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

EB-PA

Active Comparator group

Description:

One capsule to be taken after breakfast once a day for 30 days

Treatment:

Dietary Supplement: EB-PA

Placebo

Placebo Comparator group

Description:

One capsule to be taken after breakfast once a day for 30 days

Treatment:

Dietary Supplement: Placebo