- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07224867
The Effects of Liquid IV's Multi-Ingredient Recovery Supplement on Muscle Recovery Following Exercise
The Effects of Liquid IV's Multi-Ingredient Recovery Supplement, on Muscle Recovery Following Exercise: A Randomized Crossover Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eric Sikorski, PhD
- Phone Number: 8138678888
- Email: esikorski@theaspi.com
Study Contact Backup
- Name: Gabe Wilson, PhD
- Phone Number: 8138678888
- Email: gwilson@theaspi.com
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33634
- Applied Science & Performance Institute
-
Contact:
- Eric Sikorski, PhD
- Phone Number: 8138678888
- Email: esikorski@theaspi.com
-
Principal Investigator:
- Eric Sikorski, PhD
-
Sub-Investigator:
- Jacob Wilson, PhD
-
Contact:
- Gabe Wilson, PhD
- Phone Number: 8138678888
- Email: gwilson@theaspi.com
-
Sub-Investigator:
- Gabe Wilson, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy males or females aged 18-55 years old.
- Must be recreationally trained or trained/developmental as previously defined (McKay et al., 2021).
- Able to read and write in English.
- Cessation of current use of tart cherry extract, protein powders, essential amino acids/BCAAs, calcium fructoborate, boron, or anabolic agents for a minimum of 1 week prior to, and throughout the duration of the study.
- Willing to maintain regular supplement routine otherwise during the trial, and will not introduce or discontinue a supplement, other than what was previously mentioned.
- Will not participate in any strenuous exercise for a minimum of 1-week prior to exercise performance assessments, as well as during the days of exercise testing. Strenuous exercise as defined for this study includes ½ and full marathons (or more), heavy (i.e.,>80% 1RM) lifting, and any high intensity, physical activity that could make your muscles sore.
- During the study, you agree not to take any NSAIDs or other anti-inflammatory medications.
Exclusion Criteria:
- Sedentary
- Highly trained/national level or professional athlete
- Known diagnosis of any cardiovascular, metabolic, musculoskeletal, endocrine, or renal disease/disorder.
- Recent musculoskeletal injury (<3-months)
- Recent orthopedic surgery (<12-months)
- History or current malignancy.
- Current respiratory infection (i.e., cold) or high temperature (fever) within the past 4-weeks.
- Previous gastrointestinal surgery within the past 12 months.
- Regular smoker.
- Regular drinker (>14 drinks per week).
- Those regularly using anti-inflammatory drugs within the last 4-weeks.
- Current use of prescription medications that may influence adaptation to exercise (hormone therapies, peptides, etc.).
- Allergies to study-related materials.
- Any condition that impairs their ability to complete the required exercises.
- Female subjects must not be pregnant or lactating.
- Are unable to provide informed consent or are non-English speakers.
- Presently using GLP-1 medications.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: proprietary post workout recovery supplement
Liquid I.V. post workout recovery powder mixture
|
proprietary post workout recovery supplement
|
|
Placebo Comparator: Control Treatment
inactive/inert placebo mixture
|
inactive/inert placebo mix
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower Body Power and Force Generation (Maximal Countermovement Jump (CMJ))
Time Frame: Taken at baseline testing, 24 hour, 48 hour, and 72 hour.
|
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)
Time Frame: Tested at baseline, 24 hour, 48 hour, and 72 hour.
|
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
Time Frame: Taken at baseline testing, 24 hours, 48 hours, and 72 hours timepoints.
|
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.
|
Taken at baseline testing, 24 hours, 48 hours, and 72 hours timepoints.
|
|
Perceived Body Soreness Likert Scale
Time Frame: Taken at baseline testing, 24 hour, 48 hour, and 72 hour timepoints.
|
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)
Time Frame: NPRS will be taken at baseline, 24 hour, 48 hour and 72 hour time points
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body Hydration Status (InBody)
Time Frame: taken during baseline testing only - before exercise and again at ~10 minutes post treatment
|
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.
|
taken during baseline testing only - before exercise and again at ~10 minutes post treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Eric Sikorski, PhD, Applied Science and Performance Institute
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00089373
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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