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Clinical Trial Summary

This study is a double-blind, randomized, placebo-controlled, crossover clinical trial of N=40 recreationally active men to be recruited a single investigational center in Ohio (i.e., The Center for Applied Health Sciences). Subjects will take a daily protein supplement (e.g., 15 g of pea protein or 15 g of pea protein + probiotic blend) for 4 weeks, have a 1-week washout period (i.e. meaning they will not take either supplement), and then take the alternate protein supplement for an additional 4 weeks. Outcome variables include plasma amino acids, muscle damage, muscle recovery, and GI tolerance.


Clinical Trial Description

This study is a double-blind, randomized, placebo-controlled, crossover clinical trial of N=40 recreationally active men to be recruited a single investigational center in Ohio (i.e., The Center for Applied Health Sciences). Subjects will take a daily protein supplement (e.g., 15 g of pea protein or 15 g of pea protein + probiotic blend) for 4 weeks, have a 1-week washout period (i.e. meaning they will not take either supplement), and then take the alternate protein supplement for an additional 4 weeks. Subjects will attend 6 study visits. During Visit 1, subjects will be screened for participation (i.e., medical history, physical exam, routine blood work, background baseline diet). During Visit 2, subjects will get their vitals measured and become randomized into a treatment group. During visits 3 and 5, subjects will get their blood drawn to measure plasma amino acid (AA) responses before and 30, 60, 90, 120, 180 min post-ingestion of their protein test beverage (i.e., pea protein vs. pea protein + probotic) followed by an exhaustive workout to induce single leg muscle damage. During visits 4 and 6, subjects will get their blood drawn to measure the extent of muscle damage and assess their recovery. Also, during visits 3-6 subjects will undergo subjective assessments [markers of recovery (Perceived Recovery Scale) and visual analog scales (VAS) to assess changes in perceived recovery, GI gas and bloating, fatigue, muscle soreness/tightness, mood, and energy] and lower body girth measurements. Comprehensive side effect profile/ adverse event monitoring will take place throughout the study duration. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05657314
Study type Interventional
Source The Center for Applied Health Sciences, LLC
Contact
Status Completed
Phase N/A
Start date January 6, 2022
Completion date October 6, 2022

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