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.

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 Overview

• Status: Completed
• Conditions: Muscle Strength
• Intervention / Treatment: Other: Placebo without Exercise; Other: Placebo with Exercise; Other: IP I; Other: IP II; Other: IP III

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Maharashtra
    • Mumbai, Maharashtra, India, 411046
      • Vedic Lifesciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Males aged 20 - 35 years with active lifestyle moderate physical activity level as per International Physical Activity Questionnaire.
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:

1. Engaged in structured weight training during the previous 12 months prior to screening.
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 without Exercise; 2 Capsules to be taken 30 minutes before breakfast.
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: Placebo with Exercise; 2 Capsules to be taken 30 minutes before breakfast.
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 I; 2 Capsules to be taken 30 minutes before breakfast.
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 II; 2 Capsules to be taken 30 minutes before breakfast.
Other: 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.	Other: IP III; 2 Capsules to be taken 30 minutes before breakfast.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0 to Day 28 and /or day56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat composition: Lean Muscle Mass by Dual-energy X-ray absorptiometry	Increase in lean muscle mass by DXA	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	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	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.	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.	Day 0 to Day 28 and /or day56

Collaborators and Investigators

• Sponsor: Vedic Lifesciences Pvt. Ltd.
• Investigators: Principal Investigator: Dr, Anjali Jain, BHMS, Vedic Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): November 17, 2021

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 21, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EB/200301/POLY/SMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No