Muscle Mass and StrengthNCT05926609
A Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goers
A study testing EB-PA in people with Muscle Mass and Strength, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Mass and Strength
- What is being tested?
- EB-PA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesIndia
- Study dates
- 27 Jul 2023to 15 Dec 2023
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
2 sites in 1 country.
India2 sites, 2 recruiting
- Not yet recruiting
Dr. Kumta Solanki's Clinic
Mumbai, Maharashtra, 400053
Dr. Kumta Solanki, BAMS, MD, +919820511900, drkumtamali0607@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 Placebo-Controlled, Single-Blind Sequential Study to Evaluate the Efficacy of EB-PA on Muscle Mass and Strength in Occasional Gym Goer
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.
- Conditions
- Muscle Mass and Strength
- Being tested
- EB-PA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EB-PADietary supplement
1 capsule to be taken after breakfast once a day
PlaceboDietary supplement
1 capsule to be taken after breakfast once a day
| Study group | Role | What they receive |
|---|---|---|
| EB-PA | Active comparator | One capsule to be taken after breakfast once a day for 30 days Receives: Dietary Supplement: EB-PA |
| Placebo | Placebo comparator | One capsule to be taken after breakfast once a day for 30 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
Measured: Day 31
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
Measured: Day 61
Secondary outcomes (7)
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Increase in the lower-body strength (Peak anaerobic power output (PAPw)) as assessed by a vertical jump test
Measured: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Improvement in upper body strength as assessed by medicine ball throw test
Measured: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
The flexibility of the hamstrings as assessed using the V sit-and-reach test
Measured: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Improvement in muscle mass as indicated by an increase in fat-free mass (FFM) by DXA
Measured: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Decrease in central obesity as indicated by a decrease in android fat percentage by DXA.
Measured: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Improvement in metabolic health as indicated by the waist-to-height ratio (WHtR)
Measured: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Improves muscle protein synthesis as assessed by an increase in serum insulin at 0, 1 \& 3 hours post IP administration.
Measured: Day 0, Day 31 and Day 61
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start27 Jul 2023
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Mass and StrengthStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Single-blind, placebo - controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 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
- NCT05926609
- Sponsor's protocol ID
- EB/230201/EB-PA/MMS
- Status last verified
- Aug 2023
- First submitted
- 22 Jun 2023
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05926609
- Acronym / sponsor ID
- EB/230201/EB-PA/MMS
- Conditions
- Muscle Mass and Strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 3 Jul 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, placebo - controlled trial
| Arm | Type | Receives |
|---|---|---|
| EB-PA | Active comparator | Dietary Supplement: EB-PAOne capsule to be taken after breakfast once a day for 30 days |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboOne capsule to be taken after breakfast once a day for 30 days |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| EB-PA1 capsule to be taken after breakfast once a day | Dietary supplement | EB-PA |
| Placebo1 capsule to be taken after breakfast once a day | Dietary supplement | Placebo |
Primary outcome
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
Time frame: Day 31
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on
Time frame: Day 61
Improvement in muscle strength as assessed by isokinetic peak torque (measured during knee extension and flexion)
7 secondary outcomes
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Time frame: Day 0, Day 31 and Day 61
To assess the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) on
Time frame: Day 0, Day 31 and Day 61
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Muscle Mass and Strength
Recruiting
Efficacy of Robotic Upper Limb Rehabilitation Training in Patients With Tetraplegia
Tetraplegia/Tetraparesis, Rehabilitation Treatment
Recruiting
Effects of Resistance Exercise Among TGD Individuals Initiating Estrogen-Based Gender-Affirming Hormone Therapy
Muscle Mass and Strength
Recruiting
Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication
Obesity & Overweight, Muscle Mass and Strength
Active, not recruiting
Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly
Sarcopenia in Elderly, Sarcopenia
RecruitingObservational study
Significance of Estrogen Status for Muscle Function, Physical Fitness, and Physiological Health Parameters - a Comparison of Age-matched Groups of Women Before and After Menopause.
Muscle Mass and Strength, Menopause
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EB-PA in people with Muscle Mass and Strength, run by Vedic Lifesciences Pvt. Ltd. at 2 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 9 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 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 the effect of 30 days (Baseline to end of treatment period) administration of investigational product (IP) from baseline on (time frame: Day 31). 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 24 Aug 2023; AzTrials last refreshed its copy on 26 Oct 2026.