NCT05159375

Effects of Protein Hydrolysate Supplementation Influencing Strength Recovery and Expression of Muscle Damage Markers Post-exercise

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Nuritas Ltd · Industry
• Sex: Male
• Age: 30 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Muscle Injury

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Elio	Elio™ supplementation, a protein hydrolysate derived from fava bean protein extract
OTHER	SMCC	Placebo comparator

Timeline

• Start date: 2021-08-06
• Primary completion: 2022-01-22
• Completion: 2022-04-04
• First posted: 2021-12-16
• Last updated: 2023-11-21

Locations

1 site across 1 country: Ireland