An interventional study of Placebo without Exercise and Placebo with Exercise in Muscle Strength, sponsored by Vedic Lifesciences Pvt. Ltd.. Completed at 1 site in India. Open to male participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-22.
Sponsored by Vedic Lifesciences Pvt. Ltd. · Not applicable, Interventional, and Other
Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.
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.
Vedic Lifesciences Pvt. Ltd. is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: 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.
Other: 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.
Other: 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.
Other: 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.
Other: IP III
2 Capsules to be taken 30 minutes before breakfast.
2 Capsules to be taken 30 minutes before breakfast.
2 Capsules to be taken 30 minutes before breakfast.
2 Capsules to be taken 30 minutes before breakfast.
2 Capsules to be taken 30 minutes before breakfast.
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
Time frame: Day 0 to Day 28 and /or day56
Body fat composition: Lean Muscle Mass by Dual-energy X-ray absorptiometry
Increase in lean muscle mass by DXA
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Day 0 to Day 28 and /or day56
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Vedic Lifesciences Pvt. Ltd.