Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001726842
Ethics application status
Approved
Date submitted
11/11/2021
Date registered
17/12/2021
Date last updated
16/06/2023
Date data sharing statement initially provided
17/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can muscle growth and strength gains from weight training in young, active, healthy adults be affected by supplementing with palmitoylethanolamide?
Scientific title
Palmitoylethanolamide (PEA) as an adjuvant to resistance training – can PEA augment muscle growth, power and strength in young, active, healthy adults when combined with resistance training?
Secondary ID [1] 305610 0
Nil known
Universal Trial Number (UTN)
U1111-1270-6893
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skeletal muscle 324059 0
Condition category
Condition code
Musculoskeletal 321572 321572 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an 11-week double-blind randomised controlled, parallel-arm trial designed to test the hypothesis that the nutraceutical compound palmitoylethanolamide (PEA) will improve muscle mass and strength/power when combined with resistance training, and that wellbeing, post exercise muscle soreness, menstrual pains and sleep quality will be improved during the study in participants supplementing their diet with PEA vs placebo.

Participants aged 18-35 years will complete a background and medical questionnaire as well as a physical activity questionnaire via a telephone screening test to determine eligibility. Upon meeting the eligibility requirements, they will then participate in familiarisation testing and be randomised (pair-matched based on sex, baseline lean mass and baseline strength) to receive either: 1) Levagen+ which is a nutritional supplement with PEA as the active component or 2) a similar pill composed of maltodextrin not containing any PEA.

Levagen+ is composed of 90% PEA and 10% LipiSperse delivery system. LipiSperse is a mixture of excipients that enhances the absorption of PEA by a factor of ~1.8 meaning that 175 mg (150mg of PEA) of Levagen+ is equivalent to a standard dose of 300 mg of PEA. On training days, we will utilise an oral dose of 175 mg of Levagen+ pre-workout in the pre-workout meal and 175mg of Levagen+ 1hr prior to going to sleep. On non-training days participants will be requested to take 175mg of Levagen+ at breakfast and 175mg of Levagen+ 1h prior to going to sleep. Supplementation adherence will be assessed via pill counts at the end of the study.

Participants will be supplemented during 8 weeks of progressive resistance training. The progressive resistance exercise training sessions will be conducted within Deakin University, individually tailored and supervised by experienced exercise trainers. All participants will train twice a week separated by 48–72 hours recovery to minimise fatigue and reduce risk of injury for 45-60 minutes, this includes warm-up, training, and cool down. In the case of missed exercise sessions, catch up sessions will be offered.

Exercise logs and completed exercise cards will be regularly checked by the trainers and will be used to monitor exercise adherence. All outcome measures will be assessed during a familiarisation session, at baseline and post-intervention. During the first lab visit participants will be familiarised with the assessments of body composition, maximal power and maximal strength. The other measures such as sleep quality, muscle soreness, wellbeing and menstrual cycle tracking will occur at baseline and throughout the 8-week strength training phase within the 11-week study.

The resistance training intensity will be moderate to vigorous according to the % of 1 repetition maximum. The "strength" exercises will be performed at 75-90% of 1 repetition maximum and the "power" exercises will be performed at 45-60% of 1 repetition maximum. The strength exercises will be performed with a slow (2-3 seconds) eccentric phase with an explosive concentric phase. The power exercises will be performed with lower loads but will be moved as quickly as possible. The strength exercises will be; squat, bench press, deadlift and bench-pull. The power exercises will be counter-movement jump, bench press throw, deadlift jumps and Pendlay row.
Intervention code [1] 322029 0
Treatment: Other
Comparator / control treatment
Participants allocated to the comparator group will also undertake the same 8-week progressive strength training exercise program and testing as those in the intervention group, but they will consume similarly shaped/sized pills composed of maltodextrin.
Control group
Placebo

Outcomes
Primary outcome [1] 329528 0
Total body and regional (arms and legs) body composition (amount of muscle and fat) will be assessed using a non-invasive method referred to as dual energy X-ray absorptiometry (DXA)
Timepoint [1] 329528 0
Familiarisation (week 0), Baseline (week 1) and Post Testing (week 10)
Primary outcome [2] 329529 0
Muscle cross-sectional area in the thigh region will be assessed using peripheral computed tomography (pQCT)
Timepoint [2] 329529 0
Familiarisation (week 0), Baseline (week 1) and Post Testing (week 10)
Primary outcome [3] 329530 0
Upper body strength will be assessed by 1 repetition maximum bench press.
Timepoint [3] 329530 0
Familiarisation (week 0), Baseline (week 1) and Post Testing (week 10)
Secondary outcome [1] 402872 0
Short Recovery and Stress Scale (SRSS) questionnaire will be used to assess wellbeing.
Timepoint [1] 402872 0
familiarisation (week0), baseline (week 1), Weeks 2, 5, 9 and post testing (week 10)
Secondary outcome [2] 402873 0
Visual analogue scale will be used to assess Delayed onset muscle soreness (DOMS)
Timepoint [2] 402873 0
Weeks 2, 5 and 9 after familiarisation
Secondary outcome [3] 402874 0
Sleep will be monitored using a sleep diary and an actigraphy watch
Timepoint [3] 402874 0
At baseline (week 1) and at weeks 2, 5 and 9 after familiarisation, participants will be asked to complete a sleep diary. The actigraphy watch will be used throughout the 8-week training phase to track sleep and activity.
Secondary outcome [4] 402875 0
Menstrual diary - For women participating in this project, they will also be required to fill out a menstrual diary to track their menstrual cycle.
Timepoint [4] 402875 0
Throughout the 8-week training phase
Secondary outcome [5] 402876 0
Fat mass in the thigh region via pQCT
Timepoint [5] 402876 0
Familiarisation (week 0), Baseline (week 1) and Post Testing (week 10)
Secondary outcome [6] 402877 0
Food diary - At baseline, participants will also be asked to record their food intake on the day before their testing session. They will be asked to eat the same food again before the final testing of this study as a strategy to standardise food intake prior to testing. Participant’s food intake will also be assessed on two days (one weekday plus one weekend-day) using a food record at the beginning and the completion of this study to ensure that participants complied with our request to maintain their normal eating habits throughout the 11-week study period.
Timepoint [6] 402877 0
Throughout the 8-week training phase
Secondary outcome [7] 403735 0
Upper body power will be assessed by bench press throw
Timepoint [7] 403735 0
Familiarisation (week 0), Baseline (week 1) and Post Testing (week 10)
Secondary outcome [8] 403736 0
Lower body strength will be assessed by isometric mid-thigh pull
Timepoint [8] 403736 0
Familiarisation (week 0), Baseline (week 1) and Post Testing (week 10)
Secondary outcome [9] 403737 0
Lower body power will be assessed by counter movement jump
Timepoint [9] 403737 0
Familiarisation (week 0), Baseline (week 1) and Post Testing (week 10)
Secondary outcome [10] 404343 0
Bone density in the thigh region via pQCT
Timepoint [10] 404343 0
Familiarisation (week 0), Baseline (week 1) and Post Testing (week 10)

Eligibility
Key inclusion criteria
Key inclusion criteria: 1) Male or female 18-35 years of age and have had double COVID-19 vaccination done 2) recreationally active and non-resistance trained 3) have maintained a stable weight for the past 2 months (no more than ±2 kgs of weight change) 4) currently not consuming any other prescribed or non-prescribed analgesics
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded based on the following: 1) they self-report as having had a musculoskeletal injury in the past 6 months 2) participation in structured resistance training in the past 6 months 3) allergies to any of the contents of the Levagen+ supplement 4)BMI <18.5 or BMI >28 5) currently participating in a weight loss program or special diet (e.g. Low carbohydrate, ketogenic, vegan etc) 6) current smokers 7) acute or terminal illness, functional impairment that would limit inclusion in the trial 8) use of sports supplements or pain medication in the last month 9) current chronic disease including cancer, diabetes, cardiovascular disease, chronic liver disease, and gastrointestinal disorders that affects nutrient absorption 10) cognitive impairment or inability to commit to the study and its requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Individuals interested in participating in the study will contact the research team at Deakin University to find out more about the study. They will be initially screened on the telephone to determine if they qualify for the study based on the above inclusion/exclusion criteria.
Participants will then be asked to come into Deakin university for a familiarisation session where we will conduct assessments of body composition, maximal power and maximal strength. Some of these measurements will be used to pair-match participants prior to randomisation into experimental groups. Participants will be pair-matched based on sex, baseline lean mass and baseline strength (isometric mid-thigh pull) before being randomised into placebo or treatment groups. Randomisation will be at the level of the
individual participant (ID) using a computer-generated random number sequence by an independent researcher not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be computer-generated (random number sequence) by an independent researcher.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It has been calculated that a sample size of 42 participants (21 per group) will provide 80% power, for a=0.05, to detect a 2% difference between groups in percentage lean mass change. To allow for an ~10% dropout rate, we will aim to recruit 52 subjects in total. We should therefore be adequately powered to detect a meaningful increase in muscle mass in the Levagen+ group above that of the placebo group. Appropriate statistical testing will be utilised for each set of outcome measures. For instance, for assessing pre to post training changes in body composition, percentage change scores will be calculated for each participant and between-group comparisons will be made using t-tests if the data meets parametric assumptions, with the Mann-Whitney U test as the non-parametric alternative. For other outcomes, linear regression models will be used to compare groups on the post-treatment outcome while adjusting for baseline levels (ANCOVA approach). Within-group changes in outcomes will also be assessed using the appropriate statistical methods, for example paired t-tests. All tests will be two-tailed with statistical significance set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/03/2022
Actual
14/03/2022
Date of last participant enrolment
Anticipated
23/01/2023
Actual
19/02/2023
Date of last data collection
Anticipated
10/04/2023
Actual
23/04/2023
Sample size
Target
52
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 309972 0
Commercial sector/Industry
Name [1] 309972 0
Gencor Pacific Ltd
Country [1] 309972 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Institute for Physical Activity and Nutrition Research
Deakin University
221 Burwood Highway
Burwood
Melbourne
Victoria 3125
Country
Australia
Secondary sponsor category [1] 311017 0
None
Name [1] 311017 0
Address [1] 311017 0
Country [1] 311017 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309683 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 309683 0
Ethics committee country [1] 309683 0
Australia
Date submitted for ethics approval [1] 309683 0
31/08/2021
Approval date [1] 309683 0
14/02/2022
Ethics approval number [1] 309683 0
2021-312

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115030 0
Dr David Lee Hamilton
Address 115030 0
Deakin University
Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 115030 0
Australia
Phone 115030 0
+61 3 92445207
Fax 115030 0
Email 115030 0
[email protected]
Contact person for public queries
Name 115031 0
David Lee Hamilton
Address 115031 0
Deakin University
Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 115031 0
Australia
Phone 115031 0
+61 3 92445207
Fax 115031 0
Email 115031 0
[email protected]
Contact person for scientific queries
Name 115032 0
David Lee Hamilton
Address 115032 0
Deakin University
Waurn Ponds Campus, 75 Pigdons, Waurn Ponds, VIC 3216
Country 115032 0
Australia
Phone 115032 0
+61 3 92445207
Fax 115032 0
Email 115032 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures and appendices).
When will data be available (start and end dates)?
Immediately following publication to 5 years following publication.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve aims in the approved proposal.
How or where can data be obtained?
proposals should be directed to [email protected]. To gain access, data requesters will need to sign a data access agreement.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial assessing the potential of palmitoylethanolamide (PEA) to act as an adjuvant to resistance training in healthy adults: a study protocol.2023https://dx.doi.org/10.1186/s13063-023-07199-y
N.B. These documents automatically identified may not have been verified by the study sponsor.