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.
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
Show all 12Show fewer
- 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
Show all 14Show fewer
- 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.
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 group | Role | What they receive |
|---|---|---|
| Elio (supplement under investigation) | Experimental | 3g of Elio administered orally daily with the first meal of the day for a 17 day period Receives: Dietary Supplement: Elio |
| Place | Placebo comparator | 3g 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.
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)
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.
- First posted10 May 2022
- Study start24 Sep 2020
- Primary completion9 Oct 2020
- Study completion24 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Muscle InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Nuritas Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Keogh, Principal investigator, Nuritas Ltd
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 22288008Minetto 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 16951949Calle 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 20827340Kotsis 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 26682787Benito 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 32079265Nabuco 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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Protein Hydrolysate Supplementation to Influence the Expression of Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects
- ClinicalTrials.gov ID
- NCT05367648
- Acronym / sponsor ID
- PN20.004-INTERNAL
- Conditions
- Muscle Injury
- Keywords
- muscle, function, markers, resistance, exercise, protein, hydrolysate, supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Nuritas LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Sep 2020 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 24 Nov 2020 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elio (supplement under investigation) | Experimental | Dietary Supplement: Elio3g of Elio administered orally daily with the first meal of the day for a 17 day period |
| Place | Placebo comparator | Other: Placebo3g of SMCC administered orally daily with the first meal of the day for a 17 day period |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- .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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElioElio™ supplementation, a protein hydrolysate derived from fava bean protein extract | Dietary supplement | Elio (supplement under investigation) |
| PlaceboPlacebo comparator | Other | Place |
Primary outcome
Induction of creatine kinase (CK) across a range of time points
Time frame: 19 days
Induction of detectable concentrations of CK in response to exercise induced muscle damage
1 secondary outcome
Attenuation of post-resistance exercise increases in serum CK
Time frame: 19 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 22288008Baird 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.
- Background: PubMed 16951949Minetto 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.
- Background: PubMed 20827340Calle 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.
- Background: PubMed 26682787Kotsis 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.
- Background: PubMed 32079265Benito 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.
- Background: PubMed 31221297Nabuco 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.
- Muscle and Joint Pain Costs European Economies Billions in Time and MoneyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Keogh principal investigator
Nuritas Ltd
1 site in 1 country: see every site and its status.
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.