Evidence map›Paper›PMID 37004121›Full record

ArticleTrials2023

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

Zoya Huschtscha, Jackson J Fyfe, Simon A Feros, Andrew C Betik, Christopher S Shaw, Luana C Main, Gavin Abbott, Sze-Yen Tan, Martin C Refalo, Michael Gerhardy and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 31% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 1 institution in 1 country.

Zoya HuschtschaInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Jackson J FyfeInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Simon A FerosCentre for Sport Research (CSR), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Andrew C BetikInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Christopher S ShawInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Luana C MainInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Gavin AbbottInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Sze-Yen TanInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Martin C RefaloInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Michael GerhardyCentre for Sport Research (CSR), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Emma GrunwaldSchool of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Anthony MaySchool of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Jessica SilverInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
Craig M SmithInstitute for Mental and Physical Health and Clinical Translation (IMPACT), School of Medicine, Deakin University, Geelong, 3216, Australia.
Matthew WhiteCentre for Sport Research (CSR), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia.
D Lee HamiltonInstitute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Geelong, 3216, Australia. lee.hamilton@deakin.edu.au.ORCID http://orcid.org/0000-0002-5620-4788
Deakin University · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNon-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.

methodsThis 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 registrationAustralian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12621001726842p).

Indexed as

Resistance TrainingAdolescentAdultAmidesAnalgesicsAnti-Inflammatory Agents, Non-SteroidalAustraliaDietary SupplementsEthanolaminesFemaleHumansMuscle, SkeletalMuscle StrengthPainPalmitic AcidsPisum sativumAmidesAnalgesicsAnti-Inflammatory Agents, Non-SteroidalEthanolaminespalmidrolPalmitic AcidsHypertrophyInflammationPainPalmitoylethanolamideStrength

Identifiers

PMID37004121
PMCPMC10064518
OpenAlexW4362522684

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.