Aerobic CapacityNCT03697694
To Assess the Influence of Aronox on Parameters Associated With Aerobic Performance
A study testing 500mg of Aronox® >40% polyphenol aronia extract in people with Aerobic Capacity, run by Northumbria University at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aerobic Capacity
- What is being tested?
- 500mg of Aronox® >40% polyphenol aronia extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Apr 2018to 6 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle, Tyne & Wear, NE1 8ST
About this study
Official title: Randomized, Parallel, Double-blind, Placebo Controlled, Study in Men to Assess the Influence of Aronox on Parameters Associated With Aerobic Performance
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.
Read the 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
- Conditions
- Aerobic Capacity
- Being tested
- 500mg of Aronox® >40% polyphenol aronia extract, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
500mg of Aronox® >40% polyphenol aronia extractDietary supplement
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
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| 500mg of Aronox® >40% polyphenol aronia extract | Experimental | 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 Receives: Dietary Supplement: 500mg of Aronox® >40% polyphenol aronia extract |
| 500mg of placebo | Placebo comparator | 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to fatigue
Determine the effect of Aronox® on performance (time to fatigue) during high intensity cycling exercise (time to exhaustion trial) as compared to placebo
Measured: Baseline and POST 28-35 day supplementation period
Secondary outcomes (2)
VO2max
Determine the effect of Aronox® vs Placebo on aerobic performance (respiratory gas analysis - V ̇O2max) during a ramp test to exhaustion
Measured: Baseline and POST 28-35 day supplementation period
Blood lactate
Determine the effect of Aronox vs Placebo on markers of human performance (blood lactate) during a submaximal exercise test.
Measured: Baseline and POST 28-35 day supplementation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start4 Apr 2018
- Primary completion15 Feb 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic CapacityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Naturex
- Responsible party
- Sponsor
- Investigators
- Glyn Howatson, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697694
- Sponsor's protocol ID
- NUAR02
- Status last verified
- Oct 2018
- First submitted
- 2 Oct 2018
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Parallel, Double-blind, Placebo Controlled, Study in Men to Assess the Influence of Aronox on Parameters Associated With Aerobic Performance
- ClinicalTrials.gov ID
- NCT03697694
- Acronym / sponsor ID
- NUAR02
- Conditions
- Aerobic Capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Naturex
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 500mg of Aronox® >40% polyphenol aronia extract | Experimental | Dietary Supplement: 500mg of Aronox® >40% polyphenol aronia extractName: 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 |
| 500mg of placebo | Placebo comparator | Other: PlaceboName: 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 500mg of Aronox® >40% polyphenol aronia extractName: 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 | Dietary supplement | 500mg of Aronox® >40% polyphenol aronia extract |
| PlaceboName: 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 | Other | 500mg of placebo |
Primary outcome
Change in time to fatigue
Time frame: Baseline and POST 28-35 day supplementation period
Determine the effect of Aronox® on performance (time to fatigue) during high intensity cycling exercise (time to exhaustion trial) as compared to placebo
2 secondary outcomes
VO2max
Time frame: Baseline and POST 28-35 day supplementation period
Blood lactate
Time frame: Baseline and POST 28-35 day supplementation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glyn Howatson principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 500mg of Aronox® >40% polyphenol aronia extract in people with Aerobic Capacity, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to fatigue (time frame: Baseline and POST 28-35 day supplementation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.