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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo without Exercise | Other | 2 Capsules to be taken 30 minutes before breakfast.
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| Placebo with Exercise | Other | 2 Capsules to be taken 30 minutes before breakfast.
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| IP I | Other | 2 Capsules to be taken 30 minutes before breakfast.
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| IP II | Other | 2 Capsules to be taken 30 minutes before breakfast.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo without Exercise | Other | 2 Capsules to be taken 30 minutes before breakfast. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr, Anjali Jain, BHMS | Vedic lifesciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vedic Lifesciences | Mumbai | Maharashtra | 411046 | India |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Arm 1 (Placebo without Exercise) Arm 2 (Placebo with Exercise) Arm 3 (IP I) Arm 4 (IP II) Arm 5 (IP III)
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| IP III | Other | 2 Capsules to be taken 30 minutes before breakfast.
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| Placebo with Exercise | Other | 2 Capsules to be taken 30 minutes before breakfast. |
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| IP I | Other | 2 Capsules to be taken 30 minutes before breakfast. |
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| IP II | Other | 2 Capsules to be taken 30 minutes before breakfast. |
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| IP III | Other | 2 Capsules to be taken 30 minutes before breakfast. |
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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 |