PeptiStrong for Muscle Strength Enhancement

Overseen By Niamh Mohan, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nuritas Ltd

Must not be taking: Muscle supplements, Metabolism drugs

Disqualifiers: Pregnancy, Diabetes, Cardiovascular, Cancer, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

72 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does require you to maintain your current lifestyle habits, including medications, as much as possible. However, if you are taking medications that may affect muscle mass, strength, or metabolism, you may need to stop, as assessed by the study's qualified investigator.

How does PeptiStrong differ from other muscle strength treatments?

PeptiStrong may be unique due to its potential use of oligopeptides, which have been shown to improve endurance performance in other contexts, suggesting a novel approach to enhancing muscle strength. Additionally, if PeptiStrong uses a nasal delivery system with cellulose derivatives, it could offer enhanced absorption and retention compared to traditional oral or injectable treatments. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

You have not gained or lost more than 5 kilograms of body weight in the past 3 months.

You agree not to take painkillers like ibuprofen and avoid drinking alcohol for a certain number of hours before each clinic visit.

You are willing to follow the exercise instructions based on the Self-motivation Questionnaire.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PeptiStrong or placebo supplementation in conjunction with an exercise program for 56 days

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PeptiStrong
• Placebo SMCC silicated micro-crystalline cellulose

Trial Overview 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.

Participant Groups

Group I: PeptiStrong - fava bean hydrolysate preparation Experimental Treatment 1 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 Group 1 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

Who Is Running the Clinical Trial?

Nuritas Ltd

Lead Sponsor

Trials

7

Recruited

400+

Findings from Research

Supplementing compressed food with maltooligosaccharides (CFMO) significantly improved heart rate recovery and maintained higher blood glucose levels while reducing post-exercise blood lactate levels in soldiers during military training.

Soy oligopeptides (CFSO) also enhanced recovery by accelerating blood lactate clearance and increasing fluid retention, but did not show significant differences in muscle injury or perceived exertion compared to other diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compressed food with added functional oligopeptides improves performance during military endurance training. Zheng, ZQ., Geng, ZH., Liu, JX., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mucosal drug delivery using cellulose derivatives as a functional polymer. [2019]

2. China pubmed.ncbi.nlm.nih.gov

Compressed food with added functional oligopeptides improves performance during military endurance training. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Potential application of silicified microcrystalline cellulose in direct-fill formulations for automatic capsule-filling machines. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Formulation and characterization of a compacted multiparticulate system for modified release of water-soluble drugs--part 1--acetaminophen. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Preparation and in vitro evaluation of gliclazide sustained-release matrix pellets: formulation and storage stability. [2013]