Clinical trial NCT05159375: Effects of Protein Hydrolysate Supplementation Influencing Strength Recovery and Expression of Muscle Damage Markers Post-exercise
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Injury
Keywords: muscle
function
markers
resistance
exercise
protein
hydrolysate
supplement
Elio
Lead sponsor: Nuritas Ltd
Sponsor class: INDUSTRY
Collaborators: name: Sports Surgery Clinic, Santry, Dublin
First posted: 2021-12-16
Enrollment: 44
Sex: MALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Males between 30 and 45 years of age
2. Participants agree to comply with study procedures. Participants agree to comply with study procedures.
3. Participants agree to abstain from taking additional supplements throughout the testing period, with particular emphasis placed upon protein-based products
4. Participants agree to maintain their normal diet and exercise routine throughout the study
5. BMI between 18.5 to 29.9 kg/m2
6. Participants agree to refrain from consuming alcohol in the 48 hrs leading up to a test day.
7. Willingness to complete questionnaires, records and diaries associated with the study and to complete all clinic visits.
8. Provide voluntary, written, informed consent to participate in the study.
9. Refrain from any sort of exhaustive physical exercise from 48 hrs prior to each test or blood draw
10. Healthy as determined by medical examination at screening visit
11. Willingness to complete food diaries during the study
12. Must have a smart phone to use the Nutritics App
13. Non-smoker

Exclusion Criteria:

1. Alcohol or drug abuse in past year
2. Participation in any other clinical trial in the last 3 months from time of randomisation
3. Volunteer has a known allergy to the test material's active or inactive ingredients
4. Volunteers with unstable medical conditions
5. Any complaints that could interfere with ability to exercise
6. Individuals who are cognitively impaired and/or who are unable to give informed consent
7. Any co-morbidities interacting with mobility or muscle metabolism of the lower limbs (e.g., arthritis, spasticity/rigidity, all neurological disorders and paralysis)
8. Creatine supplements, anticoagulants, corticosteroids, growth hormones,

   testosterone, immunosuppressants, or exogenous insulin over the previous three months
9. Presence or history of neurological disorders or significant psychiatric illness.
10. 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
11. Participation in resistance or aerobic exercise within 48 hours of the test days
12. Participation in \> 3 High-intensity Exercise sessions per Week
13. Undertake no recovery methods such as sea swims, foam rolling, cryotherapy or undue stretching during Days 14-17.
14. Have been in contact with a suspected or confirmed case of Covid-19 in the previous 14 days
15. Are Hepatitis A or B positive, HIV positive or have had a sexual partner who is infected with hepatitis or HIV

Primary outcomes:
measure: Change in strength recovery
timeFrame: Two days
Secondary outcomes:
measure: Alteration in CK
timeFrame: Three days
measure: Alterations in muscle marker IL-6
timeFrame: Three days
measure: Alterations in muscle marker LDH
timeFrame: Three days
measure: Alterations in muscle marker CRP
timeFrame: Three days
measure: Alterations in muscle marker MB
timeFrame: Three days
measure: Alterations in muscle marker TNF-α
timeFrame: Three days
measure: Alterations in muscle marker Acylcarnitine
timeFrame: Three days
measure: Alterations in muscle marker FFA
timeFrame: Three days
measure: Alterations in muscle marker NAD+
timeFrame: Three days
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Sports Surgery Clinic
state: Leinster
Study officials:
affiliation: Santry Sports Clinic
name: Andy Franklyn-Miller
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Clarkson 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.
citation: Howatson 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.
citation: Cleak MJ, Eston RG. Delayed onset muscle soreness: mechanisms and management. J Sports Sci. 1992 Aug;10(4):325-41. doi: 10.1080/02640419208729932.
citation: Ranchordas 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.