A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
NCT ID: NCT06127849
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
138 participants
INTERVENTIONAL
2023-11-28
2024-06-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Resistance Training + Placebo (Capsule) + Placebo (Sachet)
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.
Resistance Training + Placebo (Capsule) + Placebo (Sachet)
* Placebo sachet of 20 gms dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening.
* One Placebo capsule to be taken 30 minutes after sachet in the morning.
Resistance Training + Whey protein (40 gms) + Placebo (Capsule)
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.
Resistance Training + Whey protein (40 gms) + Placebo (Capsule)
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 Placebo capsule to be taken 30 minutes after whey protein in the morning
Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)
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.
Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)
* 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 EB-PA to be taken 30 minutes after whey protein in the morning
Interventions
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Resistance Training + Placebo (Capsule) + Placebo (Sachet)
* Placebo sachet of 20 gms dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening.
* One Placebo capsule to be taken 30 minutes after sachet in the morning.
Resistance Training + Whey protein (40 gms) + Placebo (Capsule)
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 Placebo capsule to be taken 30 minutes after whey protein in the morning
Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)
* 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 EB-PA to be taken 30 minutes after whey protein in the morning
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
20 Years
35 Years
MALE
Yes
Sponsors
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Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
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Locations
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Dr. Khare's Clinic
Mumbai, Maharashtra, India
Nirmala Clinic
Mumbai, Maharashtra, India
Dr. Preeti Bawaskar's Clinic
Thāne, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EB/230701/EB-PA/SMSG
Identifier Type: -
Identifier Source: org_study_id
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