RecruitingNot ApplicableNCT06837298
The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery
Sponsor
PepsiCo Global R&D
Enrollment
76 participants
Start Date
Feb 7, 2025
Study Type
INTERVENTIONAL
Conditions
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. For the last 3 days, 2/3 of them stay on the same treatment and 1/3 of them switch from placebo to PeptiStrong®.
Eligibility
Min Age: 18 YearsMax Age: 45 Years
Inclusion Criteria12
- 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.
- 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
Exclusion Criteria17
- 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.
- 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
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Interventions
OTHERPlacebo control capsules
2.4 grams (g) daily
OTHERPeptiStrong® supplement capsules with same appearance as placebo capsules
2.4 g daily
OTHERPeptiStrong® supplement capsules following muscle damaging exercise on Day 14
2.4 g placebo capsules for 14 days, then 3 days 2.4 g of PeptiStrong® capsules following one muscle damaging exercise session
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06837298
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