Skeletal Muscle Strength & GrowthNCT06127849
A Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
A study testing Resistance Training + Whey protein (40 gms) + EB-PA (500 mg) in people with Skeletal Muscle Strength & Growth, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Strength & Growth
- What is being tested?
- Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 3 sitesIndia
- Study dates
- 28 Nov 2023to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
3 sites in 1 country.
India3 sites, 3 recruiting
- Recruiting
Dr. Khare's Clinic
Mumbai, Maharashtra, 400053
Dr. Sunira Khare, BHMS, +919664056580, sunira.khare@gmail.com
- Recruiting
Nirmala Clinic
Mumbai, Maharashtra, 400101
Dr. Anand Yadav, BAMS, MD, +919594619143, ay19891711@gmail.com
- Recruiting
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, 400607
Dr. Preeti Bawaskar, BAMS, MD, +919146680080, preeti.bawaskar10@gmail.com
About this study
Official title: A Randomized, Placebo-controlled, Blinded Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
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.
- Conditions
- Skeletal Muscle Strength & Growth
- Being tested
- Resistance Training + Placebo (Capsule) + Placebo (Sachet), Resistance Training + Whey protein (40 gms) + Placebo (Capsule), Resistance Training + Whey protein (40 gms) + EB-PA (500 mg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance Training + Placebo (Capsule) + Placebo (Sachet)Dietary supplement
- 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)Dietary supplement
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)Dietary supplement
- 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
| Study group | Role | What they receive |
|---|---|---|
| Resistance Training + Placebo (Capsule) + Placebo (Sachet) | Placebo comparator | 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. Receives: Dietary Supplement: Resistance Training + Placebo (Capsule) + Placebo (Sachet) |
| Resistance Training + Whey protein (40 gms) + Placebo (Capsule) | Active comparator | 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. Receives: Dietary Supplement: Resistance Training + Whey protein (40 gms) + Placebo (Capsule) |
| Resistance Training + Whey protein (40 gms) + EB-PA (500 mg) | Active comparator | 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. Receives: Dietary Supplement: Resistance Training + Whey protein (40 gms) + EB-PA (500 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].
Measured: Day 30
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.
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].
Measured: Day 30
Secondary outcomes (7)
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.
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].
Measured: Day 0 to Day 30
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.
V sit and reach test is performed to measure the flexibility of the lower back and back thigh muscles.
Measured: Day 0 to Day 30
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.
Total body scans will be performed using a device with its scan mode already determined automatically by the device operating system within the manufacture specification.
Measured: Day 0 to Day 30
To assess the effect of IP on improvement in grip strength as indicated by increase in non-dominant hand grip strength.
Each subject will perform the test three times approximately with 25±5 sec relaxations between the session. The participant should be instructed to squeeze the dynamometer until the grip is stable. For 3 sets, the reading will be noted in Kg and an average of 3 readings will be calculated.
Measured: Day 0 to Day 30
To assess the effect of IP on Improvement in metabolic health as indicated by waist to height ratio.
Waist circumference (WC) will be measured at the end of a normal expiration using a non-stretchable measuring tape.
Measured: Day 0 to Day 30
To assess the sustained effect of IP on muscle strength as assessed by Maintenance of lower body 1 RM weight
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].
Measured: Day 30 To 37
To assess the sustained effect of IP on muscle strength as assessed by Maintenance of upper body 1RM weight
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].
Measured: Day 30 To 37
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start28 Nov 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion5 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle Strength & GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, placebo-controlled, double-blinded study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127849
- Sponsor's protocol ID
- EB/230701/EB-PA/SMSG
- Status last verified
- Jan 2024
- First submitted
- 6 Nov 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Blinded Study to Evaluate Efficacy of EB-PA as Protein Amplifier for Skeletal Muscle Strength & Growth
- ClinicalTrials.gov ID
- NCT06127849
- Acronym / sponsor ID
- EB/230701/EB-PA/SMSG
- Conditions
- Skeletal Muscle Strength & Growth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 5 Jun 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, placebo-controlled, double-blinded study
| Arm | Type | Receives |
|---|---|---|
| Resistance Training + Placebo (Capsule) + Placebo (Sachet) | Placebo comparator | Dietary Supplement: 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 + Whey protein (40 gms) + Placebo (Capsule) | Active comparator | Dietary Supplement: 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) + EB-PA (500 mg) | Active comparator | Dietary Supplement: 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Resistance Training + Placebo (Capsule) + Placebo (Sachet) |
| 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 | Dietary supplement | Resistance Training + Whey protein (40 gms) + Placebo (Capsule) |
| 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 | Dietary supplement | Resistance Training + Whey protein (40 gms) + EB-PA (500 mg) |
Primary outcome
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.
Time frame: Day 30
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].
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.
Time frame: Day 30
The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)].
7 secondary outcomes
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.
Time frame: Day 0 to Day 30
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.
Time frame: Day 0 to Day 30
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.
Time frame: Day 0 to Day 30
To assess the effect of IP on improvement in grip strength as indicated by increase in non-dominant hand grip strength.
Time frame: Day 0 to Day 30
To assess the effect of IP on Improvement in metabolic health as indicated by waist to height ratio.
Time frame: Day 0 to Day 30
To assess the sustained effect of IP on muscle strength as assessed by Maintenance of lower body 1 RM weight
Time frame: Day 30 To 37
To assess the sustained effect of IP on muscle strength as assessed by Maintenance of upper body 1RM weight
Time frame: Day 30 To 37
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance Training + Whey protein (40 gms) + EB-PA (500 mg) in people with Skeletal Muscle Strength & Growth, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shalini Srivastava, MBBS, MD (02242172300, shalini.s@vediclifesciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.