None listed
Conditions
Brief summary
Chronic analgesic use is widespread amongst active individuals and athletes. However, the most common over the counter analgesic options interfere with training adaptations and may therefore impact negatively on performance outcomes. This research project will investigate the effects of daily oral supplementation of palmitoylethanolamide (PEA - a nutraceutical analgesic) on improving muscle mass, power, strength, wellbeing and sleep in 18-35 year-old recreationally active adults while they undergo an 8-week program of whole-body, progressive resistance training. The project has been designed to test the hypothesis that supplementation with 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 taking PEA vs placebo.
Interventions
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.
Sponsors
Study design
Eligibility
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
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.