The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery

NCT06837298 | Recruiting

• 1 other identifier: PEP-2414
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Muscle Damage; Muscle

Keywords

DOMS; exercise; damaging; muscle; muscle recovery; vicia faba; fava bean; PeptiStrong

Outcome Measures

Primary Outcomes (1)

• 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)

  Following strenuous muscle damaging exercise on Day 14

Secondary Outcomes (3)

• Exercise induced expression of markers of muscle stress

  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.

  Days 14, 15, 16, 17 based on the previous 24 hours

• Fatigue index

  Baseline Day 0, Day 16 and Day 17 for each strength test

Study Arms (3)

Placebo

PLACEBO COMPARATOR

PeptiStrong® capsules 2.4 grams per day for 17 days

Other: Placebo control capsules

PeptiStrong® 17 days

EXPERIMENTAL

PeptiStrong® capsules 2.4 grams/day for 17 days

Other: PeptiStrong® supplement capsules with same appearance as placebo capsules

PeptiStrong® 3 days

EXPERIMENTAL

14 days of Placebo followed by 3 days of PeptiStrong®

Other: PeptiStrong® supplement capsules following muscle damaging exercise on Day 14

Interventions

Placebo control capsules OTHER

2.4 grams (g) daily

Placebo

PeptiStrong® supplement capsules with same appearance as placebo capsules OTHER

2.4 g daily

PeptiStrong® 17 days

PeptiStrong® supplement capsules following muscle damaging exercise on Day 14 OTHER

2.4 g placebo capsules for 14 days, then 3 days 2.4 g of PeptiStrong® capsules following one muscle damaging exercise session

PeptiStrong® 3 days

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

Gatorade Sports Science Institute at IMG Academy

Bradenton, Florida, 34210, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Kris Osterberg, PhD, RD

  PepsiCo R&D Life Sciences, Sports Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kris Osterberg, PhD, RD

CONTACT

847.707.3118; kris.osterberg@pepsico.com

Brandon Shepherd, MS

CONTACT

brandon.shepherd3@pepsico.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 20, 2025
• Study Start: February 7, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)