NCT04949789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2021

Completed
Last Updated

February 22, 2022

Status Verified

October 1, 2021

Enrollment Period

5 months

First QC Date

June 24, 2021

Last Update Submit

February 21, 2022

Conditions

Muscle Strength

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Body fat composition: Lean Muscle Mass by Dual-energy X-ray absorptiometry

    Day 0 to Day 28 and /or day56

  • Quality of Sleep: Modified Insomnia Severity Index

    Day 0 to Day 28 and /or day56

  • Visual Analogue Scale for Fatigue

    Day 0 to Day 28 and /or day56

  • Mid-thigh Girth

    Day 0 to Day 28 and /or day56

  • Digestive diary

    Day 0 to Day 28 and /or day56

Study Arms (5)

Placebo without Exercise

OTHER

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

Placebo with Exercise

OTHER

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

IP I

OTHER

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

IP II

OTHER

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

IP III

OTHER

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

Interventions

Placebo without ExerciseOTHER

2 Capsules to be taken 30 minutes before breakfast.

Placebo without Exercise
Placebo with ExerciseOTHER

2 Capsules to be taken 30 minutes before breakfast.

Placebo with Exercise
IP IOTHER

2 Capsules to be taken 30 minutes before breakfast.

IP I
IP IIOTHER

2 Capsules to be taken 30 minutes before breakfast.

IP II
IP IIIOTHER

2 Capsules to be taken 30 minutes before breakfast.

IP III

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vedic Lifesciences

Mumbai, Maharashtra, 411046, India

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr, Anjali Jain, BHMS

    Vedic lifesciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Arm 1 (Placebo without Exercise) Arm 2 (Placebo with Exercise) Arm 3 (IP I) Arm 4 (IP II) Arm 5 (IP III)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

July 2, 2021

Study Start

June 17, 2021

Primary Completion

November 17, 2021

Study Completion

November 17, 2021

Last Updated

February 22, 2022

Record last verified: 2021-10

Locations

IN(1)