Clinical trial NCT03697694: To Assess the Influence of Aronox on Parameters Associated With Aerobic Performance
Official title: Randomized, Parallel, Double-blind, Placebo Controlled, Study in Men to Assess the Influence of Aronox on Parameters Associated With Aerobic Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aerobic Capacity
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Naturex
First posted: 2018-10-05
Enrollment: 59
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* Healthy men 18-50 years of age
* Not taking dietary supplement or pre workout supplements for at least 1 month prior to study start
* Perform between 4 and 20 hours of cycling per week
* VO2 max range ≥45 and \<70 ml/kg/min
* Willing to participate and adhere to the study protocol
* Willing to not change their dietary / workout habits throughout the study
* Willing to limit berry and/or cherry intake to one portion per day
* Able to understand the participant information, health screening questionnaire and informed consent information
* Willing to participate and sign the informed consent form

Exclusion Criteria:

* BMI \>30
* History or current cardiometabolic, gastrointestinal or renal diseases
* Taking any medication that might affect the outcome of the study, such as anti-inflammatory and immunosuppressant drugs.
* Performance enhancing drugs and recreational drugs
* Orthopedic problems that include muscle tears that might affect ability to perform exercise
* Have a recent history of surgery that might affect physical performance
* Smoking
* Recent or planned change in dietary habit
* Have lost more than 6 kg in the past 6 months or planning to lose weight in the next month
* Allergy to berries
* Drinking more than 2 alcoholic beverages per day on average in a week (total 14 units)

Primary outcomes:
measure: Change in time to fatigue
timeFrame: Baseline and POST 28-35 day supplementation period
Secondary outcomes:
measure: VO2max
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Blood lactate
timeFrame: Baseline and POST 28-35 day supplementation period
Other outcomes:
measure: Aerobic performance - submaximal test power output
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance - submaximal test heart rate
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance - submaximal test rate of perceived exertion
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance- VO2max test power output
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance- VO2max test heart rate
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance- VO2max test rate of perceived exertion
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance- time to exhaustion power output
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance- time to exhaustion blood lactate
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance- time to exhaustion heart rate
timeFrame: Baseline and POST 28-35 day supplementation period
measure: Aerobic performance- time to exhaustion rate of perceived exertion
timeFrame: Baseline and POST 28-35 day supplementation period
Locations:
city: Newcastle
country: United Kingdom
facility: Northumbria University
state: Tyne & Wear
Study officials:
affiliation: Northumbria University
name: Glyn Howatson
role: PRINCIPAL_INVESTIGATOR
References: