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NCT05926609 | RECRUITING | Muscle Mass and Strength

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

Vedic Lifesciences Pvt. Ltd.

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.

Condition or disease

Muscle Mass and Strength

Intervention/treatment

EB-PA

Placebo

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : SINGLE
Primary Purpose : OTHER
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
Actual Study Start Date : 2023-07-27
Estimated Primary Completion Date : 2023-12-15
Estimated Study Completion Date : 2023-12-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 35 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: 1
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
A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers

Location Details

NCT05926609

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

NOT YET RECRUITING

India, Maharashtra

Dr. Kumta Solanki's Clinic

Mumbai, Maharashtra, India, 400053

RECRUITING

India, Maharashtra

Dr. Preeti Bawaskar's Clinic

Thane, Maharashtra, India, 400607