Muscle StrengthNCT04949789
Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.
A study testing IP I, IP II and IP III in people with Muscle Strength, run by Vedic Lifesciences Pvt. Ltd. at 1 site in India.
Trial summary
Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level. 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
- Muscle Strength
- What is being tested?
- IP I, IP II and IP III
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- 17 Jun 2021to 17 Nov 2021
- 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 moderate physical activity level as per International Physical Activity Questionnaire.
- Recreationally active but not participating in resistance type training on regular basis.
- Body mass index (BMI) 22 - 29.9 kg/ m2
- Participants with an Insomnia Severity Index score ≥7 and ≤14
- Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs. prior to the exercise lab visit.
- Fasting Glucose ≤ 110 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 during the previous 12 months prior to screening.
- Presence of chronic disease.
- Changes in body weight more than 4.5 kg (10 pounds) in the past three months.
- Participants with uncontrolled hypertension.
- Participants who are diagnosed with 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 or herbal ingredients.
- Participants 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.
- Participants who have been part of a clinical trial within 90 days prior to the screening.
- Participants who have used whey or other supplemental proteins anytime in last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-controlled, Blinded, Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.
Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.
Read the detailed description
The present study is a randomized, blinded, placebo-controlled, pilot study. Approximately 40 males aged between ≥ 20 and ≤ 35 years, will be screened. Each trial arm will have at least 5 completed after accounting for dropout/withdrawal rate of 20%. The treatment duration for all the study participants will be 28 to 56 days (Day 56 is only applicable for participants with less than 10% increase in weight leg pressed for 1 RM on Day 28. All participants in arm 1 of study will have their end of study visit on Day 28).Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.
- Conditions
- Muscle Strength
- Being tested
- Placebo without Exercise, Placebo with Exercise, IP I, IP II, IP III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo without ExerciseOther
2 Capsules to be taken 30 minutes before breakfast.
Placebo with ExerciseOther
2 Capsules to be taken 30 minutes before breakfast.
IP IOther
2 Capsules to be taken 30 minutes before breakfast.
IP IIOther
2 Capsules to be taken 30 minutes before breakfast.
IP IIIOther
2 Capsules to be taken 30 minutes before breakfast.
| Study group | Role | What they receive |
|---|---|---|
| Placebo without Exercise | Other | 2 Capsules to be taken 30 minutes before breakfast.
* Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner.
* On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. Receives: Other: Placebo without Exercise |
| Placebo with Exercise | Other | 2 Capsules to be taken 30 minutes before breakfast.
* Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner.
* On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. Receives: Other: Placebo with Exercise |
| IP I | Other | 2 Capsules to be taken 30 minutes before breakfast.
* Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner.
* On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. Receives: Other: IP I |
| IP II | Other | 2 Capsules to be taken 30 minutes before breakfast.
* Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner.
* On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. Receives: Other: IP II |
| IP III | Other | 2 Capsules to be taken 30 minutes before breakfast.
* Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner.
* On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. Receives: Other: IP III |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Repetition Maximum
The final weight lifted successfully for atleast 1 repetition but could not complete 3 repetition will be recorded as 1- RM.
Change in muscle strength as indicated by increase in 1Repetition Maximum leg press weight
Measured: Day 0 to Day 28 and /or day56
Secondary outcomes (5)
Body fat composition: Lean Muscle Mass by Dual-energy X-ray absorptiometry
Increase in lean muscle mass by DXA
Measured: Day 0 to Day 28 and /or day56
Quality of Sleep: Modified Insomnia Severity Index
Improvement in sleep quality as assessed by the modified Insomnia Severity Index
Measured: Day 0 to Day 28 and /or day56
Visual Analogue Scale for Fatigue
Reduction in fatigue level as assessed by the 11-point Visual Analogue scale for Fatigue
Measured: Day 0 to Day 28 and /or day56
Mid-thigh Girth
Increase in mid-thigh muscle-girth (prior to exercise) at midpoint between inguinal fold and superior border of patella.
Measured: Day 0 to Day 28 and /or day56
Digestive diary
Participants will be asked to fill out a paper/online digestive diary to monitor any significant changes that might occur to the digestive system due to the consumption of WPI and the IP.
there should be No significant effect on digestive system as per participant digestive diary.
Measured: Day 0 to Day 28 and /or day56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start17 Jun 2021
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm 1 (Placebo without Exercise) Arm 2 (Placebo with Exercise) Arm 3 (IP I) Arm 4 (IP II) Arm 5 (IP III)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr, Anjali Jain, BHMS, Principal investigator, Vedic lifesciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949789
- Sponsor's protocol ID
- EB/200301/POLY/SMS
- Status last verified
- Oct 2021
- First submitted
- 24 Jun 2021
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Blinded, Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.
- ClinicalTrials.gov ID
- NCT04949789
- Acronym / sponsor ID
- EB/200301/POLY/SMS
- Conditions
- Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 2 Jul 2021 (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.
Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.
Detailed description
The present study is a randomized, blinded, placebo-controlled, pilot study. Approximately 40 males aged between ≥ 20 and ≤ 35 years, will be screened. Each trial arm will have at least 5 completed after accounting for dropout/withdrawal rate of 20%. The treatment duration for all the study participants will be 28 to 56 days (Day 56 is only applicable for participants with less than 10% increase in weight leg pressed for 1 RM on Day 28. All participants in arm 1 of study will have their end of study visit on Day 28).Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Arm 1 (Placebo without Exercise) Arm 2 (Placebo with Exercise) Arm 3 (IP I) Arm 4 (IP II) Arm 5 (IP III)
| Arm | Type | Receives |
|---|---|---|
| Placebo without Exercise | Other | Other: Placebo without Exercise2 Capsules to be taken 30 minutes before breakfast. * Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner. * On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. |
| Placebo with Exercise | Other | Other: Placebo with Exercise2 Capsules to be taken 30 minutes before breakfast. * Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner. * On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. |
| IP I | Other | Other: IP I2 Capsules to be taken 30 minutes before breakfast. * Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner. * On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. |
| IP II | Other | Other: IP II2 Capsules to be taken 30 minutes before breakfast. * Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner. * On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. |
| IP III | Other | Other: IP III2 Capsules to be taken 30 minutes before breakfast. * Whey Protein (standardized for NLT 90% AA): 48 gms of Whey protein isolate (WPI) will be taken by participants daily in two divided doses of 24 gms dissolved in 200 ml of water with their breakfast and dinner. * On testing and exercise days, WPI with IP will be taken 30 mins prior to the exercise without breakfast consumption. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males aged 20 - 35 years with active lifestyle moderate physical activity level as per International Physical Activity Questionnaire.
- Recreationally active but not participating in resistance type training on regular basis.
- Body mass index (BMI) 22 - 29.9 kg/ m2
- Participants with an Insomnia Severity Index score ≥7 and ≤14
- Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs. prior to the exercise lab visit.
Key exclusion criteria (10 listed)
- Engaged in structured weight training during the previous 12 months prior to screening.
- Presence of chronic disease.
- Changes in body weight more than 4.5 kg (10 pounds) in the past three months.
- Participants with uncontrolled hypertension.
- Participants who are diagnosed with 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 |
|---|---|---|
| Placebo without Exercise2 Capsules to be taken 30 minutes before breakfast. | Other | Placebo without Exercise |
| Placebo with Exercise2 Capsules to be taken 30 minutes before breakfast. | Other | Placebo with Exercise |
| IP I2 Capsules to be taken 30 minutes before breakfast. | Other | IP I |
| IP II2 Capsules to be taken 30 minutes before breakfast. | Other | IP II |
| IP III2 Capsules to be taken 30 minutes before breakfast. | Other | IP III |
Primary outcome
1-Repetition Maximum
Time frame: Day 0 to Day 28 and /or day56
The final weight lifted successfully for atleast 1 repetition but could not complete 3 repetition will be recorded as 1- RM. Change in muscle strength as indicated by increase in 1Repetition Maximum leg press weight
5 secondary outcomes
Body fat composition: Lean Muscle Mass by Dual-energy X-ray absorptiometry
Time frame: Day 0 to Day 28 and /or day56
Quality of Sleep: Modified Insomnia Severity Index
Time frame: Day 0 to Day 28 and /or day56
Visual Analogue Scale for Fatigue
Time frame: Day 0 to Day 28 and /or day56
Mid-thigh Girth
Time frame: Day 0 to Day 28 and /or day56
Digestive diary
Time frame: Day 0 to Day 28 and /or day56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
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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.
Dr, Anjali Jain, BHMS principal investigator
Vedic lifesciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IP I, IP II and IP III in people with Muscle Strength, run by Vedic Lifesciences Pvt. Ltd. at 1 site 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 8 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: finished, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Repetition Maximum (time frame: Day 0 to Day 28 and /or day56). 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 22 Feb 2022.