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

Vedic Lifesciences

Status: Completed

Conditions: Muscle Strength

Treatments: Other: IP I; Other: IP III; Other: IP II; Other: Placebo without Exercise; Other: Placebo with Exercise

Study type: Interventional

Funder types: Industry

Identifiers

NCT04949789

EB/200301/POLY/SMS

Details and patient eligibility

About

Sponsor proposes ingredients that when added to daily whey supplementation, can lead to increased muscle strength, improves sleep quality and reduction in fatigue level.

Full 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.

Enrollment: 28 patients

Sex: Male

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

28 participants in 5 patient groups

Placebo without Exercise

Other group

Description:

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.

Treatment:

Other: Placebo without Exercise

Placebo with Exercise

Other group

Description:

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.

Treatment:

Other: Placebo with Exercise

IP I

Other group

Description:

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.

Treatment:

Other: IP I

IP II

Other group

Description:

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.

Treatment:

Other: IP II

IP III

Other group

Description:

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.

Treatment:

Other: IP III