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A randomised controlled trial assessing the potential of palmitoylethanolamide (PEA) to act as an adjuvant to resistance training in healthy adults: a study protocol

Version 2 2024-06-03, 06:48
Version 1 2023-04-06, 05:28
journal contribution
posted on 2024-06-03, 06:48 authored by Zoya HuschtschaZoya Huschtscha, Jackson FyfeJackson Fyfe, Simon FerosSimon Feros, Andrew BetikAndrew Betik, Chris ShawChris Shaw, Luana MainLuana Main, Gavin AbbottGavin Abbott, Sze Yen TanSze Yen Tan, MC Refalo, M Gerhardy, E Grunwald, A May, Jessica SilverJessica Silver, Craig SmithCraig Smith, M White, Lee HamiltonLee Hamilton
Abstract Background Non-steroidal anti-inflammatory drugs (NSAIDs) and analgesics are used frequently by athletes either prophylactically for the prevention of pain, or to accelerate recovery following an injury. However, these types of pain management strategies have been shown to inhibit signalling pathways (e.g., cyclooxygenase-2) that may hinder muscular adaptations such as hypertrophy and strength. Nutraceuticals such as palmitoylethanolamide (PEA) have analgesic properties that act via different mechanisms to NSAIDS/analgesics. Furthermore, PEA has been shown to have a positive effect on sleep and may contribute positively to muscle hypertrophy via PKB activation. Although PEA has not been widely studied in the athletic or recreationally active population, it may provide an alternative solution for pain management if it is found not to interfere with, or enhance training adaptations. Therefore, the study aim is to investigate the effects of daily PEA supplementation (Levagen + ®) with resistance training on lean body mass, strength, power and physical performance and outcomes of recovery (e.g., sleep) compared to placebo. Methods This double-blind, randomised controlled study will take place over an 11-week period (including 8-weeks of progressive resistance training). Participants for this study will be 18–35 years old, healthy active adults that are not resistance trained. Participants will attend a familiarisation (week 0), pre-testing (week 1) and final-testing (week 11). At the pre-testing and final-testing weeks, total lean body mass (dual-energy X-ray absorptiometry; DXA), total mid-thigh cross sectional area (pQCT), maximal muscular strength (1 repetition maximum bench press, isometric mid-thigh pull) and power (countermovement jump and bench throw) will be assessed. Additionally, circulating inflammatory cytokines and anabolic hormones, sleep quality and quantity (ActiGraph), pain and subjective wellbeing (questionnaires) will also be examined. Discussion This study is designed to investigate the effects that PEA may have on pre-to post intervention changes in total body and regional lean muscle mass, strength, power, sleep, subjective wellbeing, and pain associated with resistance training and menstruation compared with the placebo condition. Unlike other NSAIDs and analgesics, which may inhibit muscle protein synthesis and training adaptations, PEA which provides analgesia via alternative mechanisms may provide an alternative pain management solution. It is therefore important to determine if this analgesic compound interferes with or enhances training adaptations so that athletes and active individuals can make an informed decision on their pain management strategies. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12621001726842p).

History

Journal

Trials

Volume

24

Article number

ARTN 245

Pagination

245-

Location

England

ISSN

1745-6215

eISSN

1745-6215

Language

English

Publication classification

C1 Refereed article in a scholarly journal

Issue

1

Publisher

BMC