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sponsor decided not to move forward with study
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The purpose of this study is to evaluate the efficacy of a multi-ingredient recovery supplement . The research will focus on strength recovery and performance maintenance assessing reductions in soreness and inflammation, as well as muscle repair and damage mitigation. By investigating these key recovery metrics, this study aims to investigate the efficacy of this supplement as a solution for active individuals seeking to optimize post-exercise recovery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| proprietary post workout recovery supplement | Experimental | Liquid I.V. post workout recovery powder mixture |
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| Control Treatment | Placebo Comparator | inactive/inert placebo mixture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| proprietary post workout recovery supplement | Dietary Supplement | proprietary post workout recovery supplement |
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| Measure | Description | Time Frame |
|---|---|---|
| Lower Body Power and Force Generation (Maximal Countermovement Jump (CMJ)) | The force plate platform consists of two force plates (left & right) containing four force sensors which measure ground reaction force. The sensors are connected to a laptop and analyzed using Mechanography GRFP Research Edition® software (version 4.2-b05.53-RES). Subjects will perform three maximal vertical CMJs on a calibrated force plate. Subjects will be instructed to stand upright on the center of the force plate with feet shoulder-width apart and hands placed on the hips. Subjects will perform a maximal effort vertical jump with proper form and instructed to land with soft knees and remain still after each jump for data capture. A 30sec rest period will be provided between each trial. Data will be used to assess maximum force output (Fmax), rate of force development (RFD), jump height (inches), and maximum power (Pmax). Force curves will be reviewed for each trial, and results averaged. This will quantify full-body mechanical power under standardized, reproducible conditions. | Taken at baseline testing, 24 hour, 48 hour, and 72 hour. |
| Lower-Body Strength (Biodex Dynamometry) | Participants will complete isometric and isokinetic strength assessments, unilaterally on the dominant leg, of knee extension (ext) and flexion (flx) using a Biodex System 4 Pro dynamometer (Biodex Medical Systems, Shirley, NY). Proper positioning and stabilization will be ensured per manufacturer guidelines. Isometric testing - knee joint will be fixed @60° of flexion. Participants will perform 3 maximal effort ext/flx contractions, each lasting 5sec, with 5sec of rest between efforts. Highest recorded torque value across the 3 trials will be analyzed. Subjects will then complete isokinetic testing consisting of 5 maximal concentric knee ext and flx at an angular velocity of 60°/s. Full range of motion will be established prior to testing. Peak torque and average torque across all 5 repetitions will be recorded for analysis. All torque values will be gravity-corrected by the system software, and same technician will conduct all tests for consistency. | Tested at baseline, 24 hour, 48 hour, and 72 hour. |
| Perceived Recovery Status (PRS) Likert Scale | The PRS is a composite scale directly proportional to recovery (Laurent, et al. 2011). Hence, the purpose of the scale will be to assess the participant's recovery from the previous exercise session. Subjects will be informed that having no soreness and a high feeling of recovery is a 10, while extreme soreness and low feelings of recovery, leading to limited ability to function, is defined by a range of 0-3, adequate recovery, with some ability to function, is defined by a range of 4-7, and good recovery, with the ability to function normally, is defined by a range of 8-10. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Hydration Status (InBody) | Body hydration status will be assessed using multi-frequency bioelectrical impedance analysis (BIA) (InBody 770, InBody Co., Ltd., Seoul, South Korea). The InBody device uses direct segmental multi-frequency impedance (5 kHz to 1 MHz) to estimate water distribution across body compartments. Measurements will include total body water (TBW), extracellular water (ECW), and intracellular water (ICW) to evaluate fluid compartment status. BIA assessments will be conducted under standardized conditions with participants barefoot, standing upright with arms slightly abducted, and heels positioned on the footplate electrodes. Light, non-conductive clothing will be required, and all metal (e.g., jewelry, watches) are removed before testing. To minimize fluid variability, participants will avoid food, drink, and caffeine for at least 8 hours prior to testing. Measurements will be collected pre-supplementation and post-exercise/post supplement as part of the hydration analysis at baseline only. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sikorski, PhD | Applied Science and Performance Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Applied Science & Performance Institute | Tampa | Florida | 33634 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21574783 | Background | Skurvydas A, Brazaitis M, Venckunas T, Kamandulis S. Predictive value of strength loss as an indicator of muscle damage across multiple drop jumps. Appl Physiol Nutr Metab. 2011 Jun;36(3):353-60. doi: 10.1139/h11-023. Epub 2011 May 16. | |
| 16424141 | Background | Shimomura Y, Yamamoto Y, Bajotto G, Sato J, Murakami T, Shimomura N, Kobayashi H, Mawatari K. Nutraceutical effects of branched-chain amino acids on skeletal muscle. J Nutr. 2006 Feb;136(2):529S-532S. doi: 10.1093/jn/136.2.529S. |
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randomized, double-blind, crossover study
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| Control placebo | Dietary Supplement | inactive/inert placebo mix |
|
| Taken at baseline testing, 24 hours, 48 hours, and 72 hours timepoints. |
| Perceived Body Soreness Likert Scale | A 7-point likert scale will be used for lower body muscle soreness, after performing 5 air squats. The Likert scale is a validated instrument designed to assess self reported muscle soreness, measured across a 7-point scale. The scale ranges from 0 (no soreness), to 6 (unbearable soreness), and has good validity and reliability (Impellizzeri, F., et al., 2007). | Taken at baseline testing, 24 hour, 48 hour, and 72 hour timepoints. |
| Numeric Pain Rating Scale (NPRS) | The NPRS is a subjective 11-point numeric pain rating scale, with 0 representing "no pain" and 10 representing "unbearable pain." The Likert scale is a validated instrument designed to assess self reported pain. For this study, the subjects will be asked to assign a number to their average lower extremity joint pain (hip and knee joint pain) (Hawker et al., 2011) at the designated time points. | NPRS will be taken at baseline, 24 hour, 48 hour and 72 hour time points |
| taken during baseline testing only - before exercise and again at ~10 minutes post treatment |
| 16790484 | Background | Connolly DA, McHugh MP, Padilla-Zakour OI, Carlson L, Sayers SP. Efficacy of a tart cherry juice blend in preventing the symptoms of muscle damage. Br J Sports Med. 2006 Aug;40(8):679-83; discussion 683. doi: 10.1136/bjsm.2005.025429. Epub 2006 Jun 21. |
| 16365096 | Background | Blomstrand E, Eliasson J, Karlsson HK, Kohnke R. Branched-chain amino acids activate key enzymes in protein synthesis after physical exercise. J Nutr. 2006 Jan;136(1 Suppl):269S-73S. doi: 10.1093/jn/136.1.269S. |
| 17993794 | Background | Impellizzeri FM, Maffiuletti NA. Convergent evidence for construct validity of a 7-point likert scale of lower limb muscle soreness. Clin J Sport Med. 2007 Nov;17(6):494-6. doi: 10.1097/JSM.0b013e31815aed57. |
| 20581704 | Background | Laurent CM, Green JM, Bishop PA, Sjokvist J, Schumacker RE, Richardson MT, Curtner-Smith M. A practical approach to monitoring recovery: development of a perceived recovery status scale. J Strength Cond Res. 2011 Mar;25(3):620-8. doi: 10.1519/JSC.0b013e3181c69ec6. |