Clinical trial NCT04949789: Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.
Official title: A Randomized, Placebo-controlled, Blinded, Pilot Study to Evaluate Efficacy of Botanical Extracts as Protein Amplifier for Skeletal Muscle Strength & Growth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Strength
Lead sponsor: Vedic Lifesciences Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-02
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1 (Placebo without Exercise) Arm 2 (Placebo with Exercise) Arm 3 (IP I) Arm 4 (IP II) Arm 5 (IP III)
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 1-Repetition Maximum
timeFrame: Day 0 to Day 28 and /or day56
Secondary outcomes:
measure: Body fat composition: Lean Muscle Mass by Dual-energy X-ray absorptiometry
timeFrame: Day 0 to Day 28 and /or day56
measure: Quality of Sleep: Modified Insomnia Severity Index
timeFrame: Day 0 to Day 28 and /or day56
measure: Visual Analogue Scale for Fatigue
timeFrame: Day 0 to Day 28 and /or day56
measure: Mid-thigh Girth
timeFrame: Day 0 to Day 28 and /or day56
measure: Digestive diary
timeFrame: Day 0 to Day 28 and /or day56
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Vedic Lifesciences
state: Maharashtra
Study officials:
affiliation: Vedic lifesciences
name: Dr, Anjali Jain, BHMS
role: PRINCIPAL_INVESTIGATOR
References: