The Effect of Vicia Faba Hydrolysate Supplementation on Muscle Strength Recovery

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®.

Study Overview

• Status: Recruiting
• Conditions: Muscle Damage; Muscle
• Intervention / Treatment: Other: Placebo control capsules; Other: PeptiStrong® supplement capsules with same appearance as placebo capsules; Other: PeptiStrong® supplement capsules following muscle damaging exercise on Day 14

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 Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kris Osterberg, PhD, RD; Phone Number: 847.707.3118; Email: kris.osterberg@pepsico.com
• Study Contact Backup: Name: Brandon Shepherd, MS; Email: brandon.shepherd3@pepsico.com

Study Locations

• United States
  • Florida
    • Bradenton, Florida, United States, 34210
      • Recruiting
      • Gatorade Sports Science Institute at IMG Academy
      • Contact: Kris Osterberg, PhD, RD; Phone Number: 847-707-3118; Email: Kris.Osterberg@pepsico.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; PeptiStrong® capsules 2.4 grams per day for 17 days	Other: Placebo control capsules; 2.4 grams (g) daily
Experimental: PeptiStrong® 17 days; PeptiStrong® capsules 2.4 grams/day for 17 days	Other: PeptiStrong® supplement capsules with same appearance as placebo capsules; 2.4 g daily
Experimental: PeptiStrong® 3 days; 14 days of Placebo followed by 3 days of PeptiStrong®	Other: PeptiStrong® 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	Baseline Day 0, Day 16 and Day 17 for each strength test

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Kris Osterberg, PhD, RD, PepsiCo R&D Life Sciences, Sports Science

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: exercise; muscle; muscle recovery; DOMS; damaging; vicia faba; fava bean; PeptiStrong
• Other Study ID Numbers: PEP-2414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No