An interventional study of Placebo control capsules and PeptiStrong® supplement capsules with same appearance as placebo capsules in Muscle Damage and Muscle, sponsored by PepsiCo Global R&D. Recruiting at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by PepsiCo Global R&D (part of PepsiCo, Inc.) · Not applicable, Interventional, and Basic science
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®.
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.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PeptiStrong® capsules 2.4 grams per day for 17 days
Other: Placebo control capsules
PeptiStrong® capsules 2.4 grams/day for 17 days
Other: PeptiStrong® supplement capsules with same appearance as placebo capsules
14 days of Placebo followed by 3 days of PeptiStrong®
Other: PeptiStrong® supplement capsules following muscle damaging exercise on Day 14
2.4 grams (g) daily
2.4 g daily
2.4 g placebo capsules for 14 days, then 3 days 2.4 g of PeptiStrong® capsules following one muscle damaging exercise session
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)
Time frame: Following strenuous muscle damaging exercise on Day 14
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
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.
Rated on a 4-item Recovery survey, anchored from none to extreme
Time frame: 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
Time frame: Baseline Day 0, Day 16 and Day 17 for each strength test
Plan to share: No
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