Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.
NCT ID: NCT04949789
Last Updated: 2022-02-22
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
28 participants
INTERVENTIONAL
2021-06-17
2021-11-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of a Plant-blend Protein Isolate on Post-exercise Myofibrillar Protein Synthesis
NCT06129513
Formulation, Phytochemical Characterization, and Clinical Assessment of a Novel Natural Supplement Targeting Body Composition in Physically Active Individuals
NCT07038135
Effect of Protein Blend Supplementation During Exercise Training on Muscle Growth and Strength
NCT01749189
Assessing the Impact of "Super-whey" vs. Isonitrogenous Whey on Muscle Protein Synthesis
NCT05701202
Vegan Whey Protein for Muscle Anabolism and Post-exercise Recovery
NCT07119749
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo without Exercise
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.
Placebo without Exercise
2 Capsules to be taken 30 minutes before breakfast.
Placebo with Exercise
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.
Placebo with Exercise
2 Capsules to be taken 30 minutes before breakfast.
IP I
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.
IP I
2 Capsules to be taken 30 minutes before breakfast.
IP II
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.
IP II
2 Capsules to be taken 30 minutes before breakfast.
IP III
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.
IP III
2 Capsules to be taken 30 minutes before breakfast.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo without Exercise
2 Capsules to be taken 30 minutes before breakfast.
Placebo with Exercise
2 Capsules to be taken 30 minutes before breakfast.
IP I
2 Capsules to be taken 30 minutes before breakfast.
IP II
2 Capsules to be taken 30 minutes before breakfast.
IP III
2 Capsules to be taken 30 minutes before breakfast.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Recreationally active but not participating in resistance type training on regular basis.
3. Body mass index (BMI) 22 - 29.9 kg/ m2
4. Participants with an Insomnia Severity Index score ≥7 and ≤14
5. Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs. prior to the exercise lab visit.
6. Fasting Glucose ≤ 110 mg/ dl
7. Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg
8. TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L
Exclusion Criteria
2. Presence of chronic disease.
3. Changes in body weight more than 4.5 kg (10 pounds) in the past three months.
4. Participants with uncontrolled hypertension.
5. Participants who are diagnosed with Type II Diabetes Mellitus.
6. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders.
7. Allergy to whey or herbal ingredients.
8. 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.
9. Participants who have been part of a clinical trial within 90 days prior to the screening.
10. Participants who have used whey or other supplemental proteins anytime in last 3 months
20 Years
35 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Vedic Lifesciences Pvt. Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dr, Anjali Jain, BHMS
Role: PRINCIPAL_INVESTIGATOR
Vedic lifesciences
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vedic Lifesciences
Mumbai, Maharashtra, India
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EB/200301/POLY/SMS
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.