Randomized, Parallel, Double-blind, Placebo Controlled, Study in Men to Assess the Influence of Aronox on Parameters Associated With Recovery Following Muscle Damaging Exercise

A randomized, double blind, counterbalanced, placebo controlled independent groups design. Prior to the visit, participants will be given a participant information sheet to inform of the procedure and requirements and undergo initial screening via email or telephone to ascertain suitability to participate. If interested parties wish to participate, then they will be invited for a familiarisation visit, where they will:

• Be provided with an overview of the protocol and given the opportunity to ask questions
• Complete a health and physical activity questionnaire to ascertain study suitability
• Complete a training status questionnaire
• Assessment of ability to swallow capsules
• Complete an informed consent to participate in the study (assuming they meet the criteria and are willing to participate)

Stature, body mass, blood pressure and heart rate will be assessed. Participants will then be familiarized with the performance tests (MVC, vertical jump and sprint performance) and randomized to an investigational product group (2 groups: Aronox vs placebo; 1:1 allocation). The first investigational dose will be administered in the laboratory and participants will be given a 4-week supply of the investigational product to take in the morning with breakfast. Participants will also be asked to keep a food and activity diary for the 3 days preceding the baseline visit and for the duration of the damaging-recovery protocol.

Following this supplementation period (28 days), participants will be asked to return to the lab in a fed (not less than 2 hours prior to the visit) and hydrated state. Participants will also be asked to abstain from strenuous exercise and caffeine for 24 h prior to each lab visit. Stature, body mass, blood pressure and heart rate will be assessed. This will be followed by baseline assessment of muscle damage which will consist of visual analogue scales to assess lower limb muscle soreness (DOMS); pain pressure threshold and baseline measures of functional performance (maximal voluntary contraction, vertical jump performance and sprint performance) and limb girth. Furthermore, a blood sample will be taken to analyze creatine kinase (index of muscle damage). This will be followed by a strenuous bout of exercise designed to cause muscle damage comprising of 100 drop jumps from a 0.6 m platform at a rate of 1 jump every 10 seconds. A short rest will be provided after every 20 jumps. Each jump is performed by the participant stepping from the platform and landing two-footed on the floor and descending quickly to ~90° and 'explosively jumping upward with maximum effort. This model for muscle damage has been used on numerous occasions in the literature and has been used with great success in our own laboratory. Participants will then return to the lab at 24, 48 and 72 h post damaging protocol where muscle damage measures will be repeated to assess the level of recovery between the groups.

Exercise protocol details Muscle damage will be induced using a drop jump protocol our laboratory has used previously. It consists of 100 drop jumps performed 10 seconds apart with a 2-minute rest period provided every 20 jumps. Each jump will be conducted from a 0.6 m high box; upon landing, participants descend to a ~90º knee angle before performing a maximal effort vertical jump.