RECRUITING

The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery

Conditions

Muscle Damage Muscle DOMS exercise damaging muscle recovery vicia faba fava bean PeptiStrong

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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®.

Official Title

The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery

Quick Facts

Study Start:2025-02-07

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06837298

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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

Contacts and Locations

Study Contact

Kris Osterberg, PhD, RD

CONTACT

847.707.3118

kris.osterberg@pepsico.com

Brandon Shepherd, MS

CONTACT

brandon.shepherd3@pepsico.com

Principal Investigator

Kris Osterberg, PhD, RD

PRINCIPAL_INVESTIGATOR

PepsiCo R&D Life Sciences, Sports Science

Study Locations (Sites)

Gatorade Sports Science Institute at IMG Academy

Bradenton, Florida, 34210

United States

Collaborators and Investigators

Sponsor: PepsiCo Global R&D

Kris Osterberg, PhD, RD, PRINCIPAL_INVESTIGATOR, PepsiCo R&D Life Sciences, Sports Science

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-07

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2025-02-07

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

DOMS
exercise
damaging
muscle
muscle recovery
vicia faba
fava bean
PeptiStrong

Additional Relevant MeSH Terms

Muscle Damage
Muscle