Muscle InjuryNCT05159375
Effects of Protein Hydrolysate Supplementation Influencing Strength Recovery and Expression of Muscle Damage Markers Post-exercise
A study testing Elio and SMCC in people with Muscle Injury, run by Nuritas Ltd at 1 site in Ireland.
Trial summary
A randomised placebo controlled, double-blind, 30 Volunteer trial of Elio™ administered 2.4 grams per day in assessing its effects on post-exercise strength recovery and increases in markers associated with muscle injury and exertion. 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 and SMCC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIreland
- Study dates
- 6 Aug 2021to 4 Apr 2022
- 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
- Males between 30 and 45 years of age
- Participants agree to comply with study procedures. 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.
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- Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits.
- 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 or blood draw
- Healthy as determined by medical examination at screening visit
- Willingness to complete food diaries during the study
- Must have a smart phone to use the Nutritics App
- Non-smoker
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
- Volunteer has a known allergy to the test material's active or inactive ingredients
- Volunteers with unstable medical conditions
- Any complaints that could interfere with ability to exercise
- Individuals who are cognitively impaired and/or who are unable to give informed consent
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- 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 three months
- Presence or history of neurological disorders or significant psychiatric illness.
- Any other condition which in the Investigator's opinion may adversely affect the volunteer's ability to complete the study or its measures or which may pose significant risk to the volunteer
- Participation in resistance or aerobic exercise within 48 hours of the test days
- Participation in > 3 High-intensity Exercise sessions per Week
- Undertake no recovery methods such as sea swims, foam rolling, cryotherapy or undue stretching during Days 14-17.
- 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 Strength Recovery and Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects.
A randomised placebo controlled, double-blind, 30 Volunteer trial of Elio™ administered 2.4 grams per day in assessing its effects on post-exercise strength recovery and increases in markers associated with muscle injury and exertion.
Read the detailed description
Periods of intense physical activity and exertion can lead to disruption of normal muscle homeostasis and the resultant muscle injury and recovery can impact upon quality of life especially in adult populations. Recovery post-exercise is therefore important to all active people.
There is a link between high-intensity exercise and reduced power and performance in the following exercise sessions. The effect on performance is measures as a reduced muscle force production or loss in strength and can correlate with delayed onset muscle soreness (DOMS). The reduced power/performance seen 24 hours - 7days post-exercise is affected by recovery methods applied, individual fitness levels and intensity of exercise injury.
Several theories have been proposed to explain the mechanisms underlying DOMS. These include inflammation and muscle damage.
Exercise-induced muscle damage is a transient phenomenon caused by unfamiliar, damaging exercise and is characterized by structural damage to myofibers and secondary inflammation. Signs and symptoms often persist for several days after exercise and typically include muscle soreness, elevated blood levels of intramuscular enzymes such as creatine kinase (CK), lactate dehydrogenase (LDH) and myoglobin (MB) that often result in elevations in circulating markers of inflammation such as C-reactive protein (CRP) and various interleukins. To date, extensive research has been published that explore the many recovery strategies purported to minimize indirect markers of muscle damage.
However, from a nutritional standpoint the results are weak. It is therefore important to develop nutritional products that can lessen the impact of these injuries' individuals succumb to or expedite their recovery.
Nutritional recovery strategies purported to minimise indirect markers of muscle damage and improve the inflammatory response can positively influence the recovery process after damaging exercise.
These strategies could in turn be used to prime the muscle for physical challenges.
Furthermore, there is a clear absence of natural approaches with proven evidence to address DOMS and the resulting performance declines.
Therapies such as non-steroidal anti-inflammatory drugs (NSAIDs) can be taken in the short term to reduce DOMS associated pain and inflammation. However, these drugs do not address performance strength loss linked to DOMS.
Acute injuries to discrete muscle groups can be indirectly detected by an array of systemic biomarkers, which become elevated at various time-points following the event.
This array of biomarkers represents key biochemical processes in muscle homeostasis, cellular integrity, mitochondrial function and inflammation.
Preliminary investigations in vitro and in vivo suggest that the administration of peptides isolated from the protein extract of fava beans, which constitute Elio™, can augment muscle protein synthesis (i.e. phospo-S6) and attenuate proteolytic signaling (i.e. Fbxo32 and Trim63) and surrogate inflammatory markers (TNFα and IL6). Thus, supporting the use of this hydrolysate in maintaining muscle homeostasis and function.
With the present study the investigators will investigate whether daily dietary supplementation of Elio™, over the course of 15 days can prime the muscle by improving strength recovery and attenuating the expression of systemic markers associated with muscle injury and over exertion following resistance type exercise in a healthy male population.
Objectives
To determine the effect of Elio™ supplementation, a protein hydrolysate derived from fava bean protein extract, on strength recovery and markers of muscle health, injury and function following strenuous resistance type exercise in male volunteers, aged between 30 and 45 years old following 17 days of supplementation.
- Conditions
- Muscle Injury
- Being tested
- Elio, SMCC
- 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
SMCCOther
Placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Elio (supplement under investigation) | Experimental | 2.4g of Elio administered orally daily with the first meal of the day for a 17 day period Receives: Dietary Supplement: Elio |
| Placebo | Placebo comparator | 2.4g of SMCC administered orally daily with the first meal of the day for a 17 day period Receives: Other: SMCC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in strength recovery
Change in strength recovery post-resistance exercise as measured by peak torque from an isokinetic leg extension strength test between groups, ELIOTM and Placebo, at day 16 and day 17.
Measured: Two days
Secondary outcomes (9)
Alteration in CK
Attenuation of post-resistance exercise increases in creatine kinase (CK) as measured by ELISA compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Alterations in muscle marker IL-6
Attenuation of post-resistance exercise alterations in IL-6 marker (pg/mL) related to muscle homeostasis compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Alterations in muscle marker LDH
Attenuation of post-resistance exercise alterations in LDH marker (U/L) related to muscle homeostasis compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Alterations in muscle marker CRP
Attenuation of post-resistance exercise alterations in CRP marker (μL/mL) related to muscle homeostasis compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Alterations in muscle marker MB
Attenuation of post-resistance exercise alterations in MB marker (nM/L) related to muscle homeostasis compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Alterations in muscle marker TNF-α
Attenuation of post-resistance exercise alterations in Tissue Necrosis Factor-α (TNFα) marker (pg/mL) related to muscle homeostasis compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Alterations in muscle marker Acylcarnitine
Attenuation of post-resistance exercise alterations in Acylcarnitine marker (nMol/mL) related to muscle homeostasis compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Alterations in muscle marker FFA
Attenuation of post-resistance exercise alterations in Free Fatty Acids (FFA) marker (mmol/L) related to muscle homeostasis compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Alterations in muscle marker NAD+
Attenuation of post-resistance exercise alterations in NAD+ marker (arbitrary units) related to muscle homeostasis compared to Placebo after 14 days, 16 days and 17 days post-resistance exercise.
Measured: Three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start6 Aug 2021
- Primary completion22 Jan 2022
- Study completion4 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuritas Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sports Surgery Clinic, Santry, Dublin
- Responsible party
- Sponsor
- Investigators
- Andy Franklyn-Miller, Principal investigator, Santry Sports Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159375
- Sponsor's protocol ID
- PN20.004.01
- Status last verified
- Jun 2022
- First submitted
- 27 Sep 2021
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herrlinger KA, Chirouzes DM, Ceddia MA. Supplementation with a polyphenolic blend improves post-exercise strength recovery and muscle soreness. Food Nutr Res. 2015 Dec 18;59:30034. doi: 10.3402/fnr.v59.30034. eCollection 2015.
PubMed 26689317Clarkson PM, Hubal MJ. Exercise-induced muscle damage in humans. Am J Phys Med Rehabil. 2002 Nov;81(11 Suppl):S52-69. doi: 10.1097/00002060-200211001-00007.
PubMed 12409811Howatson G, van Someren KA. The prevention and treatment of exercise-induced muscle damage. Sports Med. 2008;38(6):483-503. doi: 10.2165/00007256-200838060-00004.
PubMed 18489195Cleak MJ, Eston RG. Delayed onset muscle soreness: mechanisms and management. J Sports Sci. 1992 Aug;10(4):325-41. doi: 10.1080/02640419208729932.
PubMed 1518094Ranchordas MK, Rogerson D, Soltani H, Costello JT. Antioxidants for preventing and reducing muscle soreness after exercise: a Cochrane systematic review. Br J Sports Med. 2020 Jan;54(2):74-78. doi: 10.1136/bjsports-2018-099599. Epub 2018 Jul 27.
PubMed 30054340
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. 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 Strength Recovery and Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects.
- ClinicalTrials.gov ID
- NCT05159375
- Acronym / sponsor ID
- PN20.004.01
- Conditions
- Muscle Injury
- Keywords
- muscle, function, markers, resistance, exercise, protein, hydrolysate, supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nuritas LtdIndustry (pharma, biotech, devices)
- Collaborators
- Sports Surgery Clinic, Santry, Dublin
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 22 Jan 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 16 Dec 2021 (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.
A randomised placebo controlled, double-blind, 30 Volunteer trial of Elio™ administered 2.4 grams per day in assessing its effects on post-exercise strength recovery and increases in markers associated with muscle injury and exertion.
Detailed description
Periods of intense physical activity and exertion can lead to disruption of normal muscle homeostasis and the resultant muscle injury and recovery can impact upon quality of life especially in adult populations. Recovery post-exercise is therefore important to all active people.
There is a link between high-intensity exercise and reduced power and performance in the following exercise sessions. The effect on performance is measures as a reduced muscle force production or loss in strength and can correlate with delayed onset muscle soreness (DOMS). The reduced power/performance seen 24 hours - 7days post-exercise is affected by recovery methods applied, individual fitness levels and intensity of exercise injury.
Several theories have been proposed to explain the mechanisms underlying DOMS. These include inflammation and muscle damage.
Exercise-induced muscle damage is a transient phenomenon caused by unfamiliar, damaging exercise and is characterized by structural damage to myofibers and secondary inflammation. Signs and symptoms often persist for several days after exercise and typically include muscle soreness, elevated blood levels of intramuscular enzymes such as creatine kinase (CK), lactate dehydrogenase (LDH) and myoglobin (MB) that often result in elevations in circulating markers of inflammation such as C-reactive protein (CRP) and various interleukins. To date, extensive research has been published that explore the many recovery strategies purported to minimize indirect markers of muscle damage.
However, from a nutritional standpoint the results are weak. It is therefore important to develop nutritional products that can lessen the impact of these injuries' individuals succumb to or expedite their recovery.
Nutritional recovery strategies purported to minimise indirect markers of muscle damage and improve the inflammatory response can positively influence the recovery process after damaging exercise.
These strategies could in turn be used to prime the muscle for physical challenges.
Furthermore, there is a clear absence of natural approaches with proven evidence to address DOMS and the resulting performance declines.
Therapies such as non-steroidal anti-inflammatory drugs (NSAIDs) can be taken in the short term to reduce DOMS associated pain and inflammation. However, these drugs do not address performance strength loss linked to DOMS.
Acute injuries to discrete muscle groups can be indirectly detected by an array of systemic biomarkers, which become elevated at various time-points following the event.
This array of biomarkers represents key biochemical processes in muscle homeostasis, cellular integrity, mitochondrial function and inflammation.
Preliminary investigations in vitro and in vivo suggest that the administration of peptides isolated from the protein extract of fava beans, which constitute Elio™, can augment muscle protein synthesis (i.e. phospo-S6) and attenuate proteolytic signaling (i.e. Fbxo32 and Trim63) and surrogate inflammatory markers (TNFα and IL6). Thus, supporting the use of this hydrolysate in maintaining muscle homeostasis and function.
With the present study the investigators will investigate whether daily dietary supplementation of Elio™, over the course of 15 days can prime the muscle by improving strength recovery and attenuating the expression of systemic markers associated with muscle injury and over exertion following resistance type exercise in a healthy male population.
Objectives
To determine the effect of Elio™ supplementation, a protein hydrolysate derived from fava bean protein extract, on strength recovery and markers of muscle health, injury and function following strenuous resistance type exercise in male volunteers, aged between 30 and 45 years old following 17 days of supplementation.
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: Elio2.4g of Elio administered orally daily with the first meal of the day for a 17 day period |
| Placebo | Placebo comparator | Other: SMCC2.4g 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 (13 listed)
- Males between 30 and 45 years of age
- Participants agree to comply with study procedures. 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
Key exclusion criteria (16 listed)
- Alcohol or drug abuse in past year
- Participation in any other clinical trial in the last 3 months from time of randomisation
- Volunteer has a known allergy to the test material's active or inactive ingredients
- Volunteers with unstable medical conditions
- Any complaints that could interfere with ability to exercise
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) |
| SMCCPlacebo comparator | Other | Placebo |
Primary outcome
Change in strength recovery
Time frame: Two days
Change in strength recovery post-resistance exercise as measured by peak torque from an isokinetic leg extension strength test between groups, ELIOTM and Placebo, at day 16 and day 17.
9 secondary outcomes
Alteration in CK
Time frame: Three days
Alterations in muscle marker IL-6
Time frame: Three days
Alterations in muscle marker LDH
Time frame: Three days
Alterations in muscle marker CRP
Time frame: Three days
Alterations in muscle marker MB
Time frame: Three days
Alterations in muscle marker TNF-α
Time frame: Three days
Alterations in muscle marker Acylcarnitine
Time frame: Three days
Alterations in muscle marker FFA
Time frame: Three days
Alterations in muscle marker NAD+
Time frame: Three 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 21 Nov 2023.
- Results publication: PubMed 26689317Herrlinger KA, Chirouzes DM, Ceddia MA. Supplementation with a polyphenolic blend improves post-exercise strength recovery and muscle soreness. Food Nutr Res. 2015 Dec 18;59:30034. doi: 10.3402/fnr.v59.30034. eCollection 2015.
- Results publication: PubMed 12409811Clarkson PM, Hubal MJ. Exercise-induced muscle damage in humans. Am J Phys Med Rehabil. 2002 Nov;81(11 Suppl):S52-69. doi: 10.1097/00002060-200211001-00007.
- Results publication: PubMed 18489195Howatson G, van Someren KA. The prevention and treatment of exercise-induced muscle damage. Sports Med. 2008;38(6):483-503. doi: 10.2165/00007256-200838060-00004.
- Results publication: PubMed 1518094Cleak MJ, Eston RG. Delayed onset muscle soreness: mechanisms and management. J Sports Sci. 1992 Aug;10(4):325-41. doi: 10.1080/02640419208729932.
- Results publication: PubMed 30054340Ranchordas MK, Rogerson D, Soltani H, Costello JT. Antioxidants for preventing and reducing muscle soreness after exercise: a Cochrane systematic review. Br J Sports Med. 2020 Jan;54(2):74-78. doi: 10.1136/bjsports-2018-099599. Epub 2018 Jul 27.
- 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.
Andy Franklyn-Miller principal investigator
Santry Sports Clinic
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 and SMCC 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 13 inclusion and 16 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 21 Nov 2023. 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?
Change in strength recovery (time frame: Two 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 NCT05159375, which also lists 5 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 21 Nov 2023.