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

NCT05159375 | Completed

• 1 other identifier: PN20.004.01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Injury

Keywords

muscle; function; markers; resistance; exercise; protein; hydrolysate; supplement; Elio

Outcome Measures

Primary Outcomes (1)

• 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.

  Two days

Secondary Outcomes (9)

• Alteration in CK

  Three days

• Alterations in muscle marker IL-6

  Three days

• Alterations in muscle marker LDH

  Three days

• Alterations in muscle marker CRP

  Three days

• Alterations in muscle marker MB

  Three days

Study Arms (2)

Elio (supplement under investigation)

EXPERIMENTAL

2.4g of Elio administered orally daily with the first meal of the day for a 17 day period

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

Other: SMCC

Interventions

Elio DIETARY_SUPPLEMENT

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

Elio (supplement under investigation)

SMCC OTHER

Placebo comparator

Placebo

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Nuritas Ltd: lead
• Sports Surgery Clinic, Santry, Dublin: collaborator

Study Sites (1)

Sports Surgery Clinic

Dublin, Leinster, Dublin 9, Ireland

Location

Related Publications (5)

• 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.

  PMID: 26689317 RESULT

• 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.

  PMID: 12409811 RESULT

• 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.

  PMID: 18489195 RESULT

• Cleak MJ, Eston RG. Delayed onset muscle soreness: mechanisms and management. J Sports Sci. 1992 Aug;10(4):325-41. doi: 10.1080/02640419208729932.

  PMID: 1518094 RESULT

• 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.

  PMID: 30054340 RESULT

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Andy Franklyn-Miller

  Santry Sports Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: December 16, 2021
• Study Start: August 6, 2021
• Primary Completion: January 22, 2022
• Study Completion: April 4, 2022
• Last Updated: November 21, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)