Effects of Protein Hydrolysate Supplement on Systemic Muscle Function Markers Following Resistance Type Exercise in Male Subjects

NCT05367648 | Completed

• 1 other identifier: PN20.004-INTERNAL
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Muscle Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Induction of creatine kinase (CK) across a range of time points

  Induction of detectable concentrations of CK in response to exercise induced muscle damage

  19 days

Secondary Outcomes (1)

• Attenuation of post-resistance exercise increases in serum CK

  19 days

Other Outcomes (2)

• Alterations in plasma IL-6 as a marker related to muscle homeostasis/inflammation compared to Baseline

  19 days

• Change in whole blood NAD+ (as a marker of metabolism) compared to baseline

  19 days

Study Arms (2)

Elio (supplement under investigation)

EXPERIMENTAL

3g of Elio administered orally daily with the first meal of the day for a 17 day period

Dietary Supplement: Elio

Place

PLACEBO COMPARATOR

3g of SMCC administered orally daily with the first meal of the day for a 17 day period

Other: Placebo

Interventions

Elio DIETARY_SUPPLEMENT

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

Elio (supplement under investigation)

Placebo OTHER

Placebo comparator

Place

Eligibility Criteria

• Age: 30 Years - 45 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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

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
• 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
• 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

Sponsors & Collaborators

• Nuritas Ltd: lead

Study Sites (1)

Nuritas Ltd

Dublin, Leinster, 2, Ireland

Location

Related Publications (6)

• 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.

  PMID: 22288008 BACKGROUND

• Minetto 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.

  PMID: 16951949 BACKGROUND

• Calle 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.

  PMID: 20827340 BACKGROUND

• Kotsis 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.

  PMID: 26682787 BACKGROUND

• Benito 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.

  PMID: 32079265 BACKGROUND

• Nabuco 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.

  PMID: 31221297 BACKGROUND

Related Links

• Muscle and Joint Pain Costs European Economies Billions in Time and Money

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Brian Keogh

  Nuritas Ltd

  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: March 25, 2022
• First Posted: May 10, 2022
• Study Start: September 24, 2020
• Primary Completion: October 9, 2020
• Study Completion: November 24, 2020
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)