NCT04949789

Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.

A Randomized, Placebo-controlled, Blinded, Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: Male
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	Placebo without Exercise	2 Capsules to be taken 30 minutes before breakfast.
OTHER	Placebo with Exercise	2 Capsules to be taken 30 minutes before breakfast.
OTHER	IP I	2 Capsules to be taken 30 minutes before breakfast.
OTHER	IP II	2 Capsules to be taken 30 minutes before breakfast.
OTHER	IP III	2 Capsules to be taken 30 minutes before breakfast.

Timeline

• Start date: 2021-06-17
• Primary completion: 2021-11-17
• Completion: 2021-11-17
• First posted: 2021-07-02
• Last updated: 2022-02-22

Locations

1 site across 1 country: India