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Muscle InjuryNCT05367648

Effects of Protein Hydrolysate Supplement on Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects

A study testing Elio in people with Muscle Injury, run by Nuritas Ltd at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The effect of exercise on serum concentrations of creatine kinase (CK) and subsequent use of protein hydrolysate supplementation, Elio, to influence the expression of CK following resistance type exercise in male subjects. Read more about this study

Who is it for?
Ages 30 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Muscle Injury
What is being tested?
Elio
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
1 siteIreland
Study dates
24 Sep 2020to 24 Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants agree to comply with study procedures
  • Participants agree to abstain from taking additional supplements throughout the testing period, with particular emphasis placed upon protein-based products
  • Participants agree to maintain their normal diet and exercise routine throughout the study
  • BMI between 18.5 to 29.9 kg/m2
  • Participants agree to refrain from consuming alcohol in the 48 hrs leading up to a test day
  • Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits
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  • Provide voluntary, written, informed consent to participate in the study.
  • Refrain from any sort of exhaustive physical exercise from 48 hrs prior to each test.
  • Healthy as determined by medical examination at screening visit
  • Willingness to complete food diaries (including two weekdays and one weekend day the week before testing) dietary intake records shall be completed before and during the study
  • Non-smoker
  • Subjects must possess a smart phone

Who cannot join

  • .Alcohol or drug abuse in past year
  • Participation in any other clinical trial in the last 3 months from time of randomisation
  • Subject has a known allergy to the test material's active or inactive ingredients
  • Subjects with unstable medical conditions
  • Clinically significant abnormal laboratory results at screening
  • Any complaints that could interfere with ability to exercise
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  • Individuals who are cognitively impaired and/or who are 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 and paralysis)
  • Creatine supplements, anticoagulants, corticosteroids, growth hormones, testosterone, immunosuppressants, or exogenous insulin over the previous six months
  • Presence or history of neurological disorders or significant psychiatric illness
  • Any other condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
  • Participation in resistance or aerobic exercise within 48 hours of Day 0, Day 4, Day 15 and Day 19 visits in this trial
  • Have been in contact with a suspected or confirmed case of Covid-19 in the previous 14 days
  • Are Hepatitis A or B positive, HIV positive or have had a sexual partner who is infected with hepatitis or HIV

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • Nuritas Ltd

    Dublin, Leinster, 2

Other trials in Ireland

About this study

Official title: The Effect of Protein Hydrolysate Supplementation to Influence the Expression of Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects

The effect of exercise on serum concentrations of creatine kinase (CK) and subsequent use of protein hydrolysate supplementation, Elio, to influence the expression of CK following resistance type exercise in male subjects. A two subject trial of Elio administered 3 grams per day in assessing its effects on post-exercise increases in markers associated with muscle injury and exertion

Read the detailed description

Following muscle injury or exertion, several muscle specific enzymes (CK, LDH), metabolites (Acylcarnitine, FFAs) and inflammatory cytokines (IL-6, CRP) display a temporal increase in expression over 24-96hrs. For example, the muscle specific isoform of CK has been demonstrated to be elevated in the serum of subjects following eccentric resistance training with increased expression from 3hrs post exercise with a peak between 72 hrs and 96 hrs post exercise and up to 120 hrs post exercise.

Similarly, post training muscle homeostasis and injury is also associated with the infiltration of white blood cell populations namely macrophages and neutrophils, this increase in infiltration is accompanied by increases in the expression of inflammatory cytokines such as IL-6 and Il-8.

Specifically, the interleukin IL-6, has been found to be increased in concentration by up to 10-fold, compared to pre-exercise baseline, when subjects complete knee extension, cardio-vascular or eccentric exercise-based routines. Similar post-exercise or injury related increases in markers such as CRP and LDH have also been identified.

While these processes form part of the natural biological processes underpinning muscle and homeostasis, excessive or chronic elevation of these factors can prolong recovery, exacerbate injury and impair performance. Therefore, developing natural interventions that enhance or augment muscle homeostasis, reduce the likelihood of muscle injury and suppress excessive post-exercise inflammatory responses (IL-6, CRP), to enhance recovery would be highly desirable.

Several studies have been conducted where the effect of naturally derived compounds or milk-based products have been explored. Recent analysis of bovine colostrum in lower-division football players demonstrated that 3g supplementation over a 6-week period could significantly reduce the expression of markers such as CK, CRP and IL-6 following Loughborough Intermittent Shuttle Tests.

This reduction in systemic markers induced by the supplementation also corresponded to an improved performance in this routine as compared to subjects receiving 3g of whey supplementation. Resistance type exercise represents an effective model to examine the effects of injury on this panel of markers and is a controlled experimental condition to investigate the efficacy of supplementation on both performance and underlying biochemical processes.

Nutritional strategies to improve post-exercise blood marker profiles are scarce, but there is evidence that the right strategy can be effective both in females and males across a lifespan.

Resistance exercise (1-RM) routines in elderly female subjects have been shown to induce increases in IL-6 and CRP; studies also show that whey supplementation can assist in suppressing post-exercise increases in IL-6. Furthermore, male endurance athletes (aged 18-45 yrs) that supplemented with DHA and EPA showed significant decreases in circulating IL-6 and CK concentrations post-isokinetic testing compared to pre-supplementation.

Therefore, it is important for this study to examine the effects of Nuritas' Elio™ product on post-resistance exercise increases in these key markers of muscle fatigue and injury.

Given the essential role of NAD+ in the regulation of multiple cellular processes known to contribute to age-related decline in cellular function (metabolic homeostasis, DNA damage repair and sirtuin activity), investigators sought to ascertain whether increased pAMPK seen upon in vitro Elio administration translated into an increase in intracellular NAD+ concentration as measured by HPLC.

Preliminary data suggested that treatment of primary human fibroblasts with Elio resulted in a statistically significant increase (p<0.05) in intracellular levels of NAD+ relative to control (mean increase of 17%, ± 6.421 S.E.M., n=4). Given the significant increase in intracellular NAD+ concentration observed in vitro following short-term Elio treatment, longer-term Elio administration in vivo was assessed as a secondary endpoint.

7.2 Introduction

The benefits of regular and routine physical activity and exercise are well documented. Frequent physical activity are necessary tools in preventing modern life-style associated diseases such as type II diabetes, obesity and other cardio-vascular conditions. Nonetheless, injuries resulting from physical activity can have a profound impact on individuals' quality of life and work-place productivity. Periods of intense physical activity and exertion can lead to disruption of normal muscle homeostasis. Resultant muscle injury and recovery can impact upon quality of life especially in adult populations. Socio-economic studies have indicated that common skeletal-muscular injuries commonly encountered by male and female populations during regular exercise account for nearly 49% of work-place absences and 60% of permanent work incapacity. Taking this into account, studies have estimated the cost of these injuries to be in excess of €200bn due to enforced absence and lack of productivity.

It is therefore important to develop products that can lessen the impact of these injuries, which individuals succumb to or expedite their recovery

Conditions
Muscle Injury
Being tested
Elio, Placebo
Keywords
muscle, function, markers, resistance, exercise, protein, hydrolysate, supplement, Elio
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElioDietary supplement

    Elio™ supplementation, a protein hydrolysate derived from fava bean protein extract

  • PlaceboOther

    Placebo comparator

Study groups in NCT05367648
Study groupRoleWhat they receive
Elio (supplement under investigation)Experimental3g of Elio administered orally daily with the first meal of the day for a 17 day period
Receives: Dietary Supplement: Elio
PlacePlacebo comparator3g of SMCC administered orally daily with the first meal of the day for a 17 day period
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Induction of creatine kinase (CK) across a range of time points

    Induction of detectable concentrations of CK in response to exercise induced muscle damage

    Measured: 19 days

Secondary outcomes (1)
  1. Attenuation of post-resistance exercise increases in serum CK

    Attenuation of post-resistance exercise alterations in markers related to muscle homeostasis compared to Baseline at Day 4, Day 15 and Day 19

    Measured: 19 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start24 Sep 2020
  3. Primary completion9 Oct 2020
  4. Study completion24 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05367648
Sponsor's protocol ID
PN20.004-INTERNAL
Status last verified
May 2022
First submitted
25 Mar 2022
Last updated
10 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baird MF, Graham SM, Baker JS, Bickerstaff GF. Creatine-kinase- and exercise-related muscle damage implications for muscle performance and recovery. J Nutr Metab. 2012;2012:960363. doi: 10.1155/2012/960363. Epub 2012 Jan 11.

    PubMed 22288008
  • Minetto MA, Rainoldi A, Gazzoni M, Ganzit GP, Saba L, Paccotti P. Interleukin-6 response to isokinetic exercise in elite athletes: relationships to adrenocortical function and to mechanical and myoelectric fatigue. Eur J Appl Physiol. 2006 Nov;98(4):373-82. doi: 10.1007/s00421-006-0285-7. Epub 2006 Sep 2.

    PubMed 16951949
  • Calle MC, Fernandez ML. Effects of resistance training on the inflammatory response. Nutr Res Pract. 2010 Aug;4(4):259-69. doi: 10.4162/nrp.2010.4.4.259. Epub 2010 Aug 31.

    PubMed 20827340
  • Kotsis V, Grassi G. The enigma of obesity-induced hypertension mechanisms in the youth. J Hypertens. 2016 Feb;34(2):191-2. doi: 10.1097/HJH.0000000000000829. No abstract available.

    PubMed 26682787
  • Benito PJ, Cupeiro R, Ramos-Campo DJ, Alcaraz PE, Rubio-Arias JA. A Systematic Review with Meta-Analysis of the Effect of Resistance Training on Whole-Body Muscle Growth in Healthy Adult Males. Int J Environ Res Public Health. 2020 Feb 17;17(4):1285. doi: 10.3390/ijerph17041285.

    PubMed 32079265
  • Nabuco HCG, Tomeleri CM, Fernandes RR, Sugihara Junior P, Cavalcante EF, Cunha PM, Antunes M, Nunes JP, Venturini D, Barbosa DS, Burini RC, Silva AM, Sardinha LB, Cyrino ES. Effect of whey protein supplementation combined with resistance training on body composition, muscular strength, functional capacity, and plasma-metabolism biomarkers in older women with sarcopenic obesity: A randomized, double-blind, placebo-controlled trial. Clin Nutr ESPEN. 2019 Aug;32:88-95. doi: 10.1016/j.clnesp.2019.04.007. Epub 2019 May 13.

    PubMed 31221297

Questions about this trial

What is this clinical trial studying?

A study testing Elio in people with Muscle Injury, run by Nuritas Ltd at 1 site in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction of creatine kinase (CK) across a range of time points (time frame: 19 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05367648, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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