CompletedNot Applicable

Effects of Pea Proteins on Muscle Damage and Recovery

United States40 participantsStarted 2022-01-06

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provide voluntary signed and dated informed consent. * Be in good health as determined by medical history and routine blood chemistries. * Age between the ages of 18 and 55 (inclusive). * Body Mass Index of 18.5-29.9 (inclusive). * Subject agrees to maintain existing dietary patterns throughout the study period apart from ingesting the provided treatment beverage. * Subject is willing and able to comply with the study and supplement protocol. * Subject agrees to abstain from alcohol, coffee, and caffeinated beverages 24 hours prior to testing on all study visits. * Subject agrees to abstain from strenuous exercise 72 hours prior to testing on all study visits. * Body weight of at least 120 pounds. * Normotensive (seated, resting systolic blood pressure \<140 mm Hg and diastolic blood pressure \< 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility. * Normal seated, resting heart rate (\<90 per minute). * Willing to duplicate their previous 24-hour and fast for 8 hours prior each study visit. Exclusion Criteria: * Individuals who have been diagnosed with liver, renal, cardiovascular, or other metabolic disease. * Use of any dietary supplements which may confound the study or its endpoints, including creatine, BCAA, HMB, betaine, beta-alanine, etc. * Use of a…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma amino acids

Timeframe: Change from baseline to 4 weeks.

Lactate dehydrogenase (LDH)

Timeframe: Change from baseline to 24 hours after acute exercise.

Creatine kinase (CK)

Timeframe: Change from baseline to 24 hours after acute exercise.

Myoglobin

Timeframe: Change from baseline to 24 hours after acute exercise.

Blood Urea Nitrogen (BUN)

Timeframe: Change from baseline to 24 hours after acute exercise.

Mid thigh circumference

Timeframe: Change from baseline to 24 hours after acute exercise.

Trial details

NCT IDNCT05657314

SponsorThe Center for Applied Health Sciences, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-06

View on ClinicalTrials.gov More Pea Proteins trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Plasma amino acids

Timeframe: Change from baseline to 4 weeks.

Lactate dehydrogenase (LDH)

Timeframe: Change from baseline to 24 hours after acute exercise.

Creatine kinase (CK)

Timeframe: Change from baseline to 24 hours after acute exercise.

Myoglobin

Timeframe: Change from baseline to 24 hours after acute exercise.

Blood Urea Nitrogen (BUN)

Timeframe: Change from baseline to 24 hours after acute exercise.

Mid thigh circumference

Timeframe: Change from baseline to 24 hours after acute exercise.