Muscle DamageNCT06837298
The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery
A study testing PeptiStrong® supplement capsules following muscle damaging exercise on Day 14 in people with Muscle Damage and Muscle, run by PepsiCo Global R&D at 1 site in United States.
Trial summary
To investigate the effect of Vicia faba protein concentrate, a protein derived from Fava bean extract, on delayed onset muscle soreness (DOMS). Participants receive either 2.4g/day of PeptiStrong® supplement capsules or placebo capsules for 14 days until a strenuous exercise session. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Damage, Muscle
- What is being tested?
- PeptiStrong® supplement capsules following muscle damaging exercise on Day 14
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females 18 - 45 years of age.
- Willing to fast overnight on the 4 testing occasions.
- Participants agree to abstain from taking additional supplements throughout the testing period, with particular emphasis placed upon protein-based products (e.g., whey or casein based protein powders; animal derived protein hydrolysates; natural supplements constituted of vegetative protein hydrolysates from rice, fava bean, pea, carrot, spirulina, broccoli, potatoes; marine derived secondary metabolite products or protein hydrolysates including Omega-3 capsules or DHA).
- Moderately active (exercise 3-5 days per week)
- Fluent in reading, writing, and speaking English
- Participants agree to maintain their normal diet and perform only light to moderate exercise for the duration of the study.
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- BMI between 18.5 and 29.9 kg/m2
- Participants agree to refrain from consuming alcohol in the 48 hours leading up to a test day.
- Willingness to complete questionnaires, records and diaries associated with the study and to complete all lab visits.
- Refrain from any exercise from 48 hours prior to each test or blood draw.
- Healthy as determined by General Health Questionnaire.
- Non-smoker
Who cannot join
- Individuals that are glucose-6-phosphate-dehydrogenase deficient. The test product in this study contains fava bean extract which may produce favism in genetically susceptible individuals.
- Alcohol or drug abuse in the past year.3. Testosterone or estrogen supplementation (not including women on oral contraceptives)
- Pregnant or nursing or planning to become pregnant.
- Participation in any other clinical trial in the past 30 days. Participation in any PepsiCo trial in the past 6 months
- Volunteers with unstable medical conditions.
- Any complaints that could interfere with the ability to exercise.
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- Individuals who are cognitively impaired or unable to give informed consent.
- Any co-morbidities interacting with mobility or muscle metabolism of the lower limbs (e.g. arthritis, spasticity / rigidity, all neurological disorders, paralysis).
- Creatine supplements, corticosteroids, NSAIDS, amino acids, injectible peptides, collagen, and nicotinamide (Vit B3/niacin).
- Presence or history of neurological disorders or significant psychiatric illness.
- Any condition the study investigator believes would interfere with eligibility following the study protocol, effect the study results, or put the subject at undue risk.
- Participation in resistance or aerobic exercise within 48 hours of the test days.
- Participation of >3 high-intensity exercise sessions per week.
- Undertake recovery methods such as sea swims, foam rolling, cryotherapy or excessive stretching during days 14-17.
- Have been in contact with a suspected or confirmed case of COVID-19 in previous 14 days.
- Are Hepatitis A- or B-positive or have had a sexual partner infected with hepatitis or HIV and not taking medication.
- Are not employed by, or have a parent, guardian, or other immediate family member employed by a company that manufactures any products that compete with any Gatorade product. If you are unsure if a company would be considered a competitor to Gatorade, let the study investigator know the name of the other company and the nature of your relationship to that company before ou sign the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brandon Shepherd, MS contact
United States1 site, 1 recruiting
- Recruiting
Gatorade Sports Science Institute at IMG Academy
Bradenton, Florida, 34210
Kris Osterberg, PhD, RD, 847-707-3118, Kris.Osterberg@pepsico.com
About this study
To investigate the effect of Vicia faba protein concentrate, a protein derived from Fava bean extract, on delayed onset muscle soreness (DOMS). Participants receive either 2.4g/day of PeptiStrong® supplement capsules or placebo capsules for 14 days until a strenuous exercise session. For the last 3 days, 2/3 of them stay on the same treatment and 1/3 of them switch from placebo to PeptiStrong®.
Read the detailed description
Delayed onset muscle soreness (DOMS) is the result of eccentric muscle contraction and is caused by small tears in the myofibrils. Damage to the muscle fibers causes pain, inflammation, and reduced range of motion which can delay recovery. Peak effects are often experienced 48 - 72 hours following the exercise session but can last up to 7 days post-exercise. Various modalities are utilized to reduce DOMS such as cryotherapy, massage, and compression. However, nutritional supplements have also been studied including Omega 3 fatty acids, creatine monohydrate, tart cherry juice, vitamin D, and probiotics.
A recent study (Kerr, et al., 2023) investigated the effects of a protein supplement (PeptiStrong®) from Vicia faba protein concentrate, a protein derived from Fava bean extract. Results showed that 17 days of 2.4 grams of PeptiStrong® significantly improved muscle strength, reduced muscle fatigue, and reduced myostatin expression during the 72 hour recovery period compared to placebo following a strenuous bout of eccentric exercise. This study aims to repeat the methods of Kerr, et al. with the addition of females and a third experimental group. In addition to 17 days of supplementation with Vicia faba Hydrolysate or placebo, a third group will be given 14 days of placebo followed by 3 days of the Vicia faba Hydrolysate supplement to determine if short-term supplementation results in a similar benefit.
- Conditions
- Muscle Damage, Muscle
- Being tested
- Placebo control capsules, PeptiStrong® supplement capsules with same appearance as placebo capsules, PeptiStrong® supplement capsules following muscle damaging exercise on Day 14
- Keywords
- DOMS, exercise, damaging, muscle, muscle recovery, vicia faba, fava bean, PeptiStrong
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo control capsulesOther
2.4 grams (g) daily
PeptiStrong® supplement capsules with same appearance as placebo capsulesOther
2.4 g daily
PeptiStrong® supplement capsules following muscle damaging exercise on Day 14Other
2.4 g placebo capsules for 14 days, then 3 days 2.4 g of PeptiStrong® capsules following one muscle damaging exercise session
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | PeptiStrong® capsules 2.4 grams per day for 17 days Receives: Other: Placebo control capsules |
| PeptiStrong® 17 days | Experimental | PeptiStrong® capsules 2.4 grams/day for 17 days Receives: Other: PeptiStrong® supplement capsules with same appearance as placebo capsules |
| PeptiStrong® 3 days | Experimental | 14 days of Placebo followed by 3 days of PeptiStrong® Receives: Other: PeptiStrong® supplement capsules following muscle damaging exercise on Day 14 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentric knee extension and flexion strength
Assessed at an angular velocity of 60°/s through the range of 0-100° knee flexion using an isokinetic dynamometer (Biodex)
Measured: Following strenuous muscle damaging exercise on Day 14
Secondary outcomes (3)
Exercise induced expression of markers of muscle stress
Plasma concentrations of IL-6, IL-15, fractalkine, irisin, FGF21, myostatin, osteocrin / PEP- 2414 Page 9 of 32 1/29/25 V6 musclin, osteonectin/SPARC
Measured: Days 14 at Baseline and 2 hrs post strenuous exercise, and on Days 16 and 17 at 10 minutes post exercise
Ratings of soreness, fatigue, pain, and tenderness.
Rated on a 4-item Recovery survey, anchored from none to extreme
Measured: Days 14, 15, 16, 17 based on the previous 24 hours
Fatigue index
Calculated from the strength tests using the following equation: (highest force - lowest force) / highest force
Measured: Baseline Day 0, Day 16 and Day 17 for each strength test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start7 Feb 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DamageStudies 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
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kris Osterberg, PhD, RD, Principal investigator, PepsiCo R&D Life Sciences, Sports Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837298
- Sponsor's protocol ID
- PEP-2414
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery
- ClinicalTrials.gov ID
- NCT06837298
- Acronym / sponsor ID
- PEP-2414
- Conditions
- Muscle Damage, Muscle
- Keywords
- DOMS, exercise, damaging, muscle, muscle recovery, vicia faba, fava bean, PeptiStrong
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 20 Feb 2025 (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.
To investigate the effect of Vicia faba protein concentrate, a protein derived from Fava bean extract, on delayed onset muscle soreness (DOMS). Participants receive either 2.4g/day of PeptiStrong® supplement capsules or placebo capsules for 14 days until a strenuous exercise session. For the last 3 days, 2/3 of them stay on the same treatment and 1/3 of them switch from placebo to PeptiStrong®.
Detailed description
Delayed onset muscle soreness (DOMS) is the result of eccentric muscle contraction and is caused by small tears in the myofibrils. Damage to the muscle fibers causes pain, inflammation, and reduced range of motion which can delay recovery. Peak effects are often experienced 48 - 72 hours following the exercise session but can last up to 7 days post-exercise. Various modalities are utilized to reduce DOMS such as cryotherapy, massage, and compression. However, nutritional supplements have also been studied including Omega 3 fatty acids, creatine monohydrate, tart cherry juice, vitamin D, and probiotics.
A recent study (Kerr, et al., 2023) investigated the effects of a protein supplement (PeptiStrong®) from Vicia faba protein concentrate, a protein derived from Fava bean extract. Results showed that 17 days of 2.4 grams of PeptiStrong® significantly improved muscle strength, reduced muscle fatigue, and reduced myostatin expression during the 72 hour recovery period compared to placebo following a strenuous bout of eccentric exercise. This study aims to repeat the methods of Kerr, et al. with the addition of females and a third experimental group. In addition to 17 days of supplementation with Vicia faba Hydrolysate or placebo, a third group will be given 14 days of placebo followed by 3 days of the Vicia faba Hydrolysate supplement to determine if short-term supplementation results in a similar benefit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo control capsulesPeptiStrong® capsules 2.4 grams per day for 17 days |
| PeptiStrong® 17 days | Experimental | Other: PeptiStrong® supplement capsules with same appearance as placebo capsulesPeptiStrong® capsules 2.4 grams/day for 17 days |
| PeptiStrong® 3 days | Experimental | Other: PeptiStrong® supplement capsules following muscle damaging exercise on Day 1414 days of Placebo followed by 3 days of PeptiStrong® |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Males and females 18 - 45 years of age.
- Willing to fast overnight on the 4 testing occasions.
- Participants agree to abstain from taking additional supplements throughout the testing period, with particular emphasis placed upon protein-based products (e.g., whey or casein based protein powders; animal derived protein hydrolysates; natural supplements constituted of vegetative protein hydrolysates from rice, fava bean, pea, carrot, spirulina, broccoli, potatoes; marine derived secondary metabolite products or protein hydrolysates including Omega-3 capsules or DHA).
- Moderately active (exercise 3-5 days per week)
- Fluent in reading, writing, and speaking English
Key exclusion criteria (17 listed)
- Individuals that are glucose-6-phosphate-dehydrogenase deficient. The test product in this study contains fava bean extract which may produce favism in genetically susceptible individuals.
- Alcohol or drug abuse in the past year.3. Testosterone or estrogen supplementation (not including women on oral contraceptives)
- Pregnant or nursing or planning to become pregnant.
- Participation in any other clinical trial in the past 30 days. Participation in any PepsiCo trial in the past 6 months
- Volunteers with unstable medical conditions.
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 |
|---|---|---|
| Placebo control capsules2.4 grams (g) daily | Other | Placebo |
| PeptiStrong® supplement capsules with same appearance as placebo capsules2.4 g daily | Other | PeptiStrong® 17 days |
| PeptiStrong® supplement capsules following muscle damaging exercise on Day 142.4 g placebo capsules for 14 days, then 3 days 2.4 g of PeptiStrong® capsules following one muscle damaging exercise session | Other | PeptiStrong® 3 days |
Primary outcome
Concentric knee extension and flexion strength
Time frame: Following strenuous muscle damaging exercise on Day 14
Assessed at an angular velocity of 60°/s through the range of 0-100° knee flexion using an isokinetic dynamometer (Biodex)
3 secondary outcomes
Exercise induced expression of markers of muscle stress
Time frame: Days 14 at Baseline and 2 hrs post strenuous exercise, and on Days 16 and 17 at 10 minutes post exercise
Ratings of soreness, fatigue, pain, and tenderness.
Time frame: Days 14, 15, 16, 17 based on the previous 24 hours
Fatigue index
Time frame: Baseline Day 0, Day 16 and Day 17 for each strength test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Brandon Shepherd, MS contact
Kris Osterberg, PhD, RD principal investigator
PepsiCo R&D Life Sciences, Sports Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeptiStrong® supplement capsules following muscle damaging exercise on Day 14 in people with Muscle Damage and Muscle, run by PepsiCo Global R&D 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: looking for participants now, as of the sponsor's last update on 20 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kris Osterberg, PhD, RD (847.707.3118, kris.osterberg@pepsico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentric knee extension and flexion strength (time frame: Following strenuous muscle damaging exercise on Day 14). 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 Feb 2025.