What side effects are associated with this type of intervention?

Common treatments for muscle injuries that focus on enhancing muscle strength and endurance include supplementation with amino acids, creatine, and other nutritional supplements. Known side effects of these treatments can vary. For example, creatine supplementation may cause gastrointestinal discomfort, muscle cramping, and dehydration. Amino acid supplements, such as leucine, have been shown to have minimal side effects but may cause nausea or stomach upset in some individuals. It is important to consult with a healthcare provider before starting any supplementation regimen to ensure it is appropriate for the individual's health status and to monitor for any adverse effects.

What prior FDA approvals exist?

FDA-approved treatments for muscle injuries and conditions often focus on enhancing muscle strength and endurance. Creatine supplementation, for example, has been shown to augment muscle strength and reduce muscle damage markers following resistance exercise. Additionally, drugs like glucocorticoids (e.g., prednisone) have been used in various muscle-related conditions, although their efficacy can vary. While specific supplements like PeptiStrong are still under investigation, the general approach of using nutritional and pharmacological interventions to support muscle function is well-established.

What other types of research exist?

Promising alternatives to PeptiStrong for enhancing muscle strength and endurance in muscle injury patients include: 1) Creatine supplementation, which has been shown to improve muscle mass and recovery. 2) Branched-Chain Amino Acids (BCAAs), which can aid in muscle repair and reduce muscle soreness. 3) Omega-3 fatty acids, which have anti-inflammatory properties and can support muscle recovery. 4) High-intensity interval training (HIIT), which can enhance muscle strength and endurance. 5) Physical therapy modalities such as electrical stimulation and resistance training, which are effective in muscle rehabilitation.

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PeptiStrong for Muscle Strength Enhancement

N/A

Recruiting

Research Sponsored by Nuritas Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males & females between 19 and 40 years of age

Hormonal contraceptives including oral contraception, hormone birth control patch, vaginal contraceptive ring, injectable contraceptives, or hormone implant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 56 days supplementation

Summary

This trial tests if the PeptiStrong supplement can improve muscle strength and endurance in healthy young men and women when combined with regular exercise.

Who is the study for?

This trial is for men and women aged 19-40 with a BMI of 18.5 to 29.9, who are willing to follow an exercise program three times a week without engaging in other vigorous activities two days before testing. Participants should maintain their current lifestyle, including diet and sleep patterns, avoid NSAIDs and alcohol before visits, and use contraception if necessary.

What is being tested?

The study tests PeptiStrong's effectiveness on muscle strength when combined with regular exercise compared to a placebo (an inactive substance). It's randomized (participants are assigned by chance) and double-blind (neither researchers nor participants know who gets what), ensuring unbiased results.

What are the potential side effects?

Potential side effects aren't specified here but generally could include digestive discomfort or allergic reactions from the supplement, as well as typical exercise-related issues like muscle soreness or strain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 19 and 40 years old.

Select...

I am using a form of hormonal birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 56 days supplementation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~56 days supplementation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days supplementation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

randomised, double-blind, placebo controlled study to evaluate the effect of PeptiStrong in conjunction with an exercise program on muscle strength in young males and females.

Secondary study objectives

To assess the effects of PeptStrong in conjunction with exercise

Other study objectives

effect of PeptiStrong in conjunction with exercise on future exploratory endpoints including blood biomarkers of muscle homeostasis pre and post exercise

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PeptiStrong - fava bean hydrolysate preparationExperimental Treatment1 Intervention

PeptiStrong 2.4g/day will be supplemented as 5 capsules (480mg each) taken with approx. 150mL water at breakfast once per day for 56 days

Group II: Silicated micro-crystalline cellulose (SMCC)Placebo Group1 Intervention

The placebo 2.4g/day will be supplemented as 5 capsules taken with approx. 150mL water at breakfast once per day for 56 days

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for muscle injuries include physical therapy, anti-inflammatory medications, and nutritional supplementation. Physical therapy helps by promoting blood flow and muscle repair through targeted exercises. Anti-inflammatory medications reduce swelling and pain, facilitating quicker recovery. Nutritional supplements, such as creatine and quercetin, enhance muscle repair and strength by providing essential nutrients and reducing oxidative stress. PeptiStrong, a supplement studied for its effects on muscle strength and endurance, likely works by supplying peptides that support muscle protein synthesis and recovery. These mechanisms are crucial for muscle injury patients as they help accelerate healing, reduce pain, and restore muscle function, enabling a quicker return to normal activities.

ICU-acquired weakness.Quercetin Supplementation Improves Neuromuscular Function Recovery from Muscle Damage.Oral creatine supplementation augments the repeated bout effect.