Clinical Trials Directory

Trials / Completed

CompletedNCT05657314

Effects of Pea Proteins on Muscle Damage and Recovery

A Comparison of Two Pea Proteins on Amino Acid Absorption, GI Tolerance, Muscle Damage and Recovery

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
The Center for Applied Health Sciences, LLC · Industry
Sex
Male
Age
18 Years – 55 Years
Healthy volunteers
Accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTActive ComparatorConsists of 15 grams of pea protein

Timeline

Start date
2022-01-06
Primary completion
2022-10-06
Completion
2022-10-06
First posted
2022-12-20
Last updated
2022-12-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05657314. Inclusion in this directory is not an endorsement.