Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The present study is a randomized, placebo-controlled, double blinded study to evaluate efficacy of EB-PA as protein amplifier for skeletal muscle strength & growth in males with active lifestyle. Approximately 160 subjects aged between ≥ 20 and ≤ 35 years will be screened and 138 participants are to be randomized. Both the IP and placebo study arms will have at least 40 completed subjects after accounting for the screening failure and dropout/withdrawal rate of 14% and 13 % respectively (Total 120 completers). The treatment duration for all the study subjects will be 30 days. The sustained effect of the product will be observed for next 7 days, wherein, the subjects will be abstaining from the protein and IP supplementation and will exercise at their ease.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resistance Training + Placebo (Capsule) + Placebo (Sachet) | Placebo Comparator | A sachet of 20 gms of Placebo dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of placebo to be taken 30 minutes after placebo sachet in the morning. |
|
| Resistance Training + Whey protein (40 gms) + Placebo (Capsule) | Active Comparator | A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of Placebo to be taken 30 minutes after whey protein in the morning. |
|
| Resistance Training + Whey protein (40 gms) + EB-PA (500 mg) | Active Comparator | A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. One capsule of EB0-PA to be taken 30 minutes after whey protein in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resistance Training + Placebo (Capsule) + Placebo (Sachet) | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in lower body 1 RM (repetition maximum) weight from baseline. | The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)]. | Day 30 |
| To assess improvement in muscle strength after administration of Investigational Product (IP) as assessed by increase in upper body 1 RM (repetition maximum) weight from baseline. | The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)]. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effect of Investigational Product (IP) on Increase in muscle endurance as assessed by increase in exercise volume calculated as load x number of repetition (upper + lower body exercise) completed at ≥70% of screening 1-RM. | The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)]. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Male
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shalini Srivastava, MBBS, MD | Contact | 02242172300 | shalini.s@vediclifesciences.com | |
| Dr. Sonali Ghosh,, BAMS | Contact | 02242172300 | sonali.g@vediclifesciences.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Khare's Clinic | Recruiting | Mumbai | Maharashtra | 400053 | India |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Randomized, placebo-controlled, double-blinded study
Not provided
Not provided
Not provided
| Resistance Training + Whey protein (40 gms) + Placebo (Capsule) | Dietary Supplement | A sachet of 20 gms of Whey protein isolate (WPI) dissolved in 200-300 ml water. One sachet to be taken in the Morning and one in the evening. - One Placebo capsule to be taken 30 minutes after whey protein in the morning |
|
| Resistance Training + Whey protein (40 gms) + EB-PA (500 mg) | Dietary Supplement |
|
|
| Day 0 to Day 30 |
| To assess the effect of Investigational Product (IP) on Increase in muscle (hamstring) flexibility as assessed by increase in distance for V sit & reach test. | V sit and reach test is performed to measure the flexibility of the lower back and back thigh muscles. | Day 0 to Day 30 |
| To assess the effect of IP on improvement in muscle mass as indicated by increase in fat free mass (FFM), lean muscle mass and android fat by DXA. | Total body scans will be performed using a device with its scan mode already determined automatically by the device operating system within the manufacture specification. | Day 0 to Day 30 |
| To assess the effect of IP on improvement in grip strength as indicated by increase in non-dominant hand grip strength. | Each subject will perform the test three times approximately with 25±5 sec relaxations between the session. The participant should be instructed to squeeze the dynamometer until the grip is stable. For 3 sets, the reading will be noted in Kg and an average of 3 readings will be calculated. | Day 0 to Day 30 |
| To assess the effect of IP on Improvement in metabolic health as indicated by waist to height ratio. | Waist circumference (WC) will be measured at the end of a normal expiration using a non-stretchable measuring tape. | Day 0 to Day 30 |
| To assess the sustained effect of IP on muscle strength as assessed by Maintenance of lower body 1 RM weight | The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)]. | Day 30 To 37 |
| To assess the sustained effect of IP on muscle strength as assessed by Maintenance of upper body 1RM weight | The maximum weight that can be lifted once with the correct lifting technique is known as the 1-RM. The 1-RM will be determined by the Brzycki equation using calculator as follows: Weight ÷ [1.0278 - (0.0278 × Number of repetitions)]. | Day 30 To 37 |
| Nirmala Clinic | Recruiting | Mumbai | Maharashtra | 400101 | India |
|
| Dr. Preeti Bawaskar's Clinic | Recruiting | Thane | Maharashtra | 400607 | India |
|
| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D002214 | Capsules |
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided