A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth

Vedic Lifesciences

Status: Enrolling

Conditions: Skeletal Muscle Strength & Growth

Treatments: Dietary Supplement: Resistance Training + Placebo (Capsule) + Placebo (Sachet); Dietary Supplement: Resistance Training + Whey protein (40 gms) + Placebo (Capsule); Dietary Supplement: Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06127849

EB/230701/EB-PA/SMSG

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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138 participants in 3 patient groups, including a placebo group

Resistance Training + Placebo (Capsule) + Placebo (Sachet)

Placebo Comparator group

Description:

A sachet of 20 gms of Placebo dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of placebo to be taken 30 minutes after placebo sachet in the morning.

Treatment:

Dietary Supplement: Resistance Training + Placebo (Capsule) + Placebo (Sachet)

Resistance Training + Whey protein (40 gms) + Placebo (Capsule)

Active Comparator group

Description:

A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of Placebo to be taken 30 minutes after whey protein in the morning.

Treatment:

Dietary Supplement: Resistance Training + Whey protein (40 gms) + Placebo (Capsule)

Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)

Active Comparator group

Description:

A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of EB0-PA to be taken 30 minutes after whey protein in the morning.

Treatment:

Dietary Supplement: Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)