To Assess the Influence of Aronox on Parameters Associated With Aerobic Performance
Condition: Aerobic Capacity
Study type: Interventional

Summary: 
      A randomized, double blind, counterbalanced, placebo controlled independent groups design.
      Participants will then be familiarized with the ergometer to determine settings and seating
      position and randomized to an investigational product group (2 groups: Aronox vs placebo; 1:1
      allocation). A time to undergo baseline testing will then be scheduled (day 0). On the
      baseline day, stature, body mass, blood pressure and heart rate will be assessed.
      Participants will then complete a submaximal aerobic performance test (lactate profile) where
      expired gas, heart rate, blood lactate,and RPE will be measured. Following a 10-min rest,
      participants will then perform a ramp test to exhaustion to determine VO2max (this will be to
      finalize eligibility to the study - VO2max of 45-70 ml/kg/min). Expired gas, heart rate,
      power output, perceived exertion, and near-infra-red spectroscopy will be collected
      throughout and blood lactate will be determined at test termination. Those that do not
      fulfill the criteria for VO2max will be excluded from the study at this point. Those that are
      eligible (verified by their VO2max) will consume a standardized 'light' meal and rest for 2
      h. Time to exhaustion (TTE) trial (60%GET) determined from previous tests (lactate profile
      and VO2max) will then be completed. On completion of the TTE trial, the first dose of the
      investigational product 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 given study diaries to complete (exercise, general health, dietary
      intake). On the final study day (day 28), remaining investigational capsules and study
      diaries will be collected to monitor compliance. An identical trial to day 0 will then be
      conducted, following which participants will be asked if they knew what supplement they were
      asked to consume and be given the chance to provide feedback on their experience.
    

Detailed description: 
      Prior to the visit, participants will be issued with a participant information sheet to
      inform of the procedure and study requirements,then undergo initial screening via email or
      telephone to ascertain suitability to participate. If interested parties wish to participate,
      then an invitation for a familiarisation visit will be made, 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)

      Exercise protocol details During the first and second visit to the laboratory, participants
      will complete cycling tests; a submaximal exercise test and an incremental ramp exercise test
      to exhaustion to elucidate maximal aerobic power (Wmax), VO2max and gas exchange threshold
      (GET); both tests will be completed using an electro-magnetically braked cycle ergometer. The
      submaximal test will require participants to begin cycling at 100 W, which will increase by
      25 W every minutes. Heart rate and capillary blood samples will taken from the earlobe in the
      last 30 s of each stage and immediately analysed for blood lactate concentration. Cycling
      will be terminated when the lactate turn-point had been reached. Throughout the submaximal
      test, near-infra-red spectroscopy (NIRS) and pulmonary gas exchange will be monitored through
      an online gas analysis system. Gas data will be averaged over the final 30 s of each stage in
      order to analyse the O2 cost. Following the completion of the submaximal test, participants
      will be given 10 minutes rest prior to completing the incremental ramp test to exhaustion to
      determine VO2max. The ramp test will consisted of 3 minutes of cycling at 100 W, followed by
      an increase in work rate of 1 W every 3 seconds (20 W.min-1) until the participant reaches
      volitional exhaustion or the cadence drops 10 rpm below the preferred cadence.
      Breath-by-breath pulmonary gas exchange data will collected throughout the ramp protocol and
      VO2max will be calculated as the highest 30-second average in oxygen consumption. Using the
      regression equation calculated from the submaximal VO2 data and the VO2max, it will then
      possible to identify the power output associated with the GET. The GET will be determined
      using either the first disproportionate increase in CO2 production (VCO2) from visual
      inspection of individual plots of VCO2 vs. VO2 or an increase in expired ventilatory
      equivalents (VE/VO2 with no increase in VE/VCO2). Following a standardized meal during a rest
      period of ~2 h, a time to exhaustion (TTE) test will be completed to examine exercise
      tolerance. The intensity for TTE test will be 60% of the difference between GET and VO2max.
      Saddle, handlebar height and fore/aft position was recorded and replicated on the return
      laboratory visit following supplementation.

      Standardized meal Descriptive measures and a Physical Activity Level (PAL) of 1.7 will be
      used to calculate the participant's individual resting energy expenditure. This will
      subsequently identify the amount of cereal (Rice Snaps, Tesco, Manchester, UK) and
      semi-skimmed milk (1g/kg/bm) each individual will need to consume to meet 10% of their daily
      energy requirements (DER). This standardized fixed-energy breakfast meal will consist of a
      cereal: milk ratio of 30 g: 120 mL and will deliver fat, protein and carbohydrate with a
      macronutrient composition of 14, 14 & 72%, respectively.

      Supplementation Following group allocation, participants will be provided with aronia
      (Aronox®) or placebo (PLA) supplementation and instructed to consume 500mg of the
      investigational product with breakfast every day for 4 weeks.

      Data Analysis:

      Statistical analysis will be performed using PASW Statistics 21.0 for Windows (SPSS, Inc.,
      Chicago, IL.). All group characteristics will be reported as means ± standard errors, unless
      otherwise stated. A two-way ANOVA tests will be used to allow for comparison of between- and
      within- group mean differences for each dependent variable. Appropriate post-hoc analysis
      will be performed to determine any location of significance. Mauchley's test will
    

Intervention name(s): 500mg of Aronox® >40% polyphenol aronia extract; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Name: Aronia PE 40% polyphenols Description: Powdered extract obtained from aronia berries (Aronia melanocarpa) Dosage form: Capsule (opaque, beige, size 00) Strength: 500 mg aronia extract Regimen 1 capsule, once a day with breakfast (except on days when attending the laboratory) Batch number: As per label Expiry Date: As per label Manufacturer: NATUREX / Virage sante; Name: Placebo Description: Identical formulation as the treatment consisting of colored maltodextrin using artificial colors Dosage form: Capsule (opaque, beige, size 00) Strength: 500 mg placebo Regimen 1 capsule, once a day with breakfast (except on days when attending the laboratory) Batch number: As per label Expiry Date: As per label Manufacturer: NATUREX (Advance nutraceutical) / Virage sante
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention