Pea ProteinsNCT05657314
Effects of Pea Proteins on Muscle Damage and Recovery
A study testing Active Comparator in people with Pea Proteins and Muscle Damage, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pea Proteins, Muscle Damage, Amino Acid Change
- What is being tested?
- Active Comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2022to 6 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 any prescription medications (particularly antibiotics and/or anti-inflammatories), or probiotics within the past 2 months which may confound the study or its endpoints.
- Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
- Smokers.
- Clinically significant abnormal laboratory results at screening.
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- Known sensitivity to any ingredient in the test formulations as listed in the Nutrition Facts label.
- Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Individuals with diabetes, asthma, chronic inflammatory conditions (e.g., rheumatoid arthritis, colitis, IBS/IBD, gout or fibromyalgia, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
- Individuals with excessive caffeine intake (600mg/day).
- Subjects who take medication which may adversely affect the measured outcomes (i.e., testosterone or other anabolic steroids, corticosteroids or testosterone replacement therapy (ingestion, injection, or transdermal), diuretics, etc.)
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- Prior gastrointestinal bypass surgery (i.e., Lapband, etc.).
- Women
- Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
- Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Center for Applied Health Sciences
Canfield, Ohio, 44406
About this study
Official title: A Comparison of Two Pea Proteins on Amino Acid Absorption, GI Tolerance, Muscle Damage and Recovery
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.
Read the 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
- Pea Proteins, Muscle Damage, Amino Acid Change
- Being tested
- Active Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ComparatorDietary supplement
Consists of 15 grams of pea protein
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | 15 grams of pea protein dissolved in 12 ounces of water. Receives: Dietary Supplement: Active Comparator |
| Active | Experimental | 15 grams of pea protein + probiotic blend (1 billion CFU/capsule - blend of Lactobacillus rhamnosus, Lactobacillus acidophilus, Saccharomyces boulardii, and Bifidobacterium breve) dissolved in 12 ounces of water. Receives: Dietary Supplement: Active Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acids
Plasma amino acid responses before and 30, 60, 90, 120, 180 min post-ingestion of the test product.
Measured: Change from baseline to 4 weeks.
Lactate dehydrogenase (LDH)
Concentration of LDH in plasma.
Measured: Change from baseline to 24 hours after acute exercise.
Creatine kinase (CK)
Concentration of CK in plasma.
Measured: Change from baseline to 24 hours after acute exercise.
Myoglobin
Concentration of myoglobin in plasma.
Measured: Change from baseline to 24 hours after acute exercise.
Blood Urea Nitrogen (BUN)
Concentration of BUN in plasma.
Measured: Change from baseline to 24 hours after acute exercise.
Mid thigh circumference
Mid thigh circumference as measured using a tape measure.
Measured: Change from baseline to 24 hours after acute exercise.
Secondary outcomes (4)
Gastro Intestinal Bloating
Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating.
Measured: 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.
Measured: Change from baseline to 4 weeks.
Fatigue
Fatigue as measured by a 10 cm visual analogue scale, where higher values represent greater fatigue.
Measured: Change from baseline to 4 weeks.
Muscle Soreness
Fatigue as measured by a 10 cm visual analogue scale, where higher values represent greater fatigue.
Measured: Change from baseline to 24 hours after acute exercise.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start6 Jan 2022
- Primary completion6 Oct 2022
- Study completion6 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pea ProteinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Center for Applied Health Sciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biohm Health, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657314
- Sponsor's protocol ID
- BIOHM-1221
- Status last verified
- Dec 2022
- First submitted
- 10 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Pea Proteins on Amino Acid Absorption, GI Tolerance, Muscle Damage and Recovery
- ClinicalTrials.gov ID
- NCT05657314
- Acronym / sponsor ID
- BIOHM-1221
- Conditions
- Pea Proteins, Muscle Damage, Amino Acid Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Center for Applied Health Sciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Biohm Health, LLC
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 6 Oct 2022 (actual)
- Study completion
- 6 Oct 2022 (actual)
- First posted
- 20 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Dietary Supplement: Active Comparator15 grams of pea protein dissolved in 12 ounces of water. |
| Active | Experimental | Dietary Supplement: Active Comparator15 grams of pea protein + probiotic blend (1 billion CFU/capsule - blend of Lactobacillus rhamnosus, Lactobacillus acidophilus, Saccharomyces boulardii, and Bifidobacterium breve) dissolved in 12 ounces of water. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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 any prescription medications (particularly antibiotics and/or anti-inflammatories), or probiotics within the past 2 months which may confound the study or its endpoints.
- Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence.
- Smokers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active ComparatorConsists of 15 grams of pea protein | Dietary supplement | Active, Comparator |
Primary outcome
Plasma amino acids
Time frame: Change from baseline to 4 weeks.
Plasma amino acid responses before and 30, 60, 90, 120, 180 min post-ingestion of the test product.
Lactate dehydrogenase (LDH)
Time frame: Change from baseline to 24 hours after acute exercise.
Concentration of LDH in plasma.
Creatine kinase (CK)
Time frame: Change from baseline to 24 hours after acute exercise.
Concentration of CK in plasma.
Myoglobin
Time frame: Change from baseline to 24 hours after acute exercise.
Concentration of myoglobin in plasma.
Blood Urea Nitrogen (BUN)
Time frame: Change from baseline to 24 hours after acute exercise.
Concentration of BUN in plasma.
Mid thigh circumference
Time frame: Change from baseline to 24 hours after acute exercise.
Mid thigh circumference as measured using a tape measure.
4 secondary outcomes
Gastro Intestinal Bloating
Time frame: Change from baseline to 4 weeks.
Gastro Intestinal Flatulence
Time frame: Change from baseline to 4 weeks.
Fatigue
Time frame: Change from baseline to 4 weeks.
Muscle Soreness
Time frame: Change from baseline to 24 hours after acute exercise.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Pea Proteins
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Active, not recruiting
Effect of the Consumption of Cookies Enriched With Plant Proteins and of a Vitamin D Supplement on the Progression of Sarcopenia in the Elderly
Sarcopenia in Elderly, Sarcopenia
Active, not recruiting
Pea Protein Oral Nutrition Supplement for the Reduction of Gastrostomy Tube Placement Rate in Patients With Locally Advanced Head and Neck Cancer Undergoing Chemoradiation Therapy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Comparator in people with Pea Proteins and Muscle Damage, run by The Center for Applied Health Sciences, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma amino acids (time frame: Change from baseline to 4 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.