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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
40
Consists of 15 grams of pea protein
The Center for Applied Health Sciences
Canfield, Ohio, United States
Plasma amino acids
Plasma amino acid responses before and 30, 60, 90, 120, 180 min post-ingestion of the test product.
Time frame: Change from baseline to 4 weeks.
Lactate dehydrogenase (LDH)
Concentration of LDH in plasma.
Time frame: Change from baseline to 24 hours after acute exercise.
Creatine kinase (CK)
Concentration of CK in plasma.
Time frame: Change from baseline to 24 hours after acute exercise.
Myoglobin
Concentration of myoglobin in plasma.
Time frame: Change from baseline to 24 hours after acute exercise.
Blood Urea Nitrogen (BUN)
Concentration of BUN in plasma.
Time frame: Change from baseline to 24 hours after acute exercise.
Mid thigh circumference
Mid thigh circumference as measured using a tape measure.
Time frame: Change from baseline to 24 hours after acute exercise.
Gastro Intestinal Bloating
Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating.
Time frame: Change from baseline to 4 weeks.
Gastro Intestinal Flatulence
Gastro-intestinal flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater gas.
Time frame: Change from baseline to 4 weeks.
Fatigue
Fatigue as measured by a 10 cm visual analogue scale, where higher values represent greater fatigue.
Time frame: Change from baseline to 4 weeks.
Muscle Soreness
Fatigue as measured by a 10 cm visual analogue scale, where higher values represent greater fatigue.
Time frame: Change from baseline to 24 hours after acute exercise.
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