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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
28
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.
Vedic Lifesciences
Mumbai, Maharashtra, India
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
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2 Capsules to be taken 30 minutes before breakfast.
2 Capsules to be taken 30 minutes before breakfast.