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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Muscle Strength

Intervention / Treatment
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* Other: Placebo without Exercise
* Other: Placebo with Exercise
* Other: IP I
* Other: IP II
* Other: IP III


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males aged 20 - 35 years with active lifestyle moderate physical activity level as per International Physical Activity Questionnaire. Recreationally active but not participating in resistance type training on regular basis. Body mass index (BMI) 22 - 29.9 kg/ m2 Participants with an Insomnia Severity Index score ≥7 and ≤14 Ready to refrain from caffeinated products and intense strength/ endurance exercise for 24 hrs. prior to the exercise lab visit. Fasting Glucose ≤ 110 mg/ dl Systolic Blood Pressure ≤ 129 mm Hg and Diastolic Blood Pressure ≤ 89 mm Hg TSH (thyroid stimulating hormone) ≥0.4 and ≤ 4.9 mIU/L Exclusion Criteria: Engaged in structured weight training during the previous 12 months prior to screening. Presence of chronic disease. Changes in body weight more than 4.5 kg (10 pounds) in the past three months. Participants with uncontrolled hypertension. Participants who are diagnosed with Type II Diabetes Mellitus. History or presence of clinically significant renal, hepatic, endocrine, biliary, gastrointestinal, pancreatic, or neurologic disorders. Allergy to whey or herbal ingredients. 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. Participants who have been part of a clinical trial within 90 days prior to the screening. Participants who have used whey or other supplemental proteins anytime in last 3 months

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Arm 1 (Placebo without Exercise) Arm 2 (Placebo with Exercise) Arm 3 (IP I) Arm 4 (IP II) Arm 5 (IP III)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Placebo without Exercise<br>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<br>* 2 Capsules to be taken 30 minutes before breakfast.<br>|
| Other: Placebo with Exercise<br>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<br>* 2 Capsules to be taken 30 minutes before breakfast.<br>|
| Other: IP I<br>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<br>* 2 Capsules to be taken 30 minutes before breakfast.<br>|
| Other: IP II<br>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<br>* 2 Capsules to be taken 30 minutes before breakfast.<br>|
| Other: IP III<br>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<br>* 2 Capsules to be taken 30 minutes before breakfast.<br>|

What is the study measuring?
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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 |