To Assess the Influence of Aronox on Parameters Associated With Aerobic Performance

NCT03697694 | Completed

• 1 other identifier: NUAR02
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Aerobic Capacity

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline and POST 28-35 day supplementation period

Secondary Outcomes (2)

• VO2max

  Baseline and POST 28-35 day supplementation period

• Blood lactate

  Baseline and POST 28-35 day supplementation period

Other Outcomes (10)

• Aerobic performance - submaximal test power output

  Baseline and POST 28-35 day supplementation period

• Aerobic performance - submaximal test heart rate

  Baseline and POST 28-35 day supplementation period

• Aerobic performance - submaximal test rate of perceived exertion

  Baseline and POST 28-35 day supplementation period

Study Arms (2)

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

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

Other: Placebo

Interventions

500mg of Aronox® >40% polyphenol aronia extract DIETARY_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

500mg of Aronox® >40% polyphenol aronia extract

Placebo OTHER

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

500mg of placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Males only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northumbria University: lead
• Naturex: collaborator

Study Sites (1)

Northumbria University

Newcastle, Tyne & Wear, NE1 8ST, United Kingdom

Location

Study Officials

• Glyn Howatson

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 5, 2018
• Study Start: April 4, 2018
• Primary Completion: February 15, 2019
• Study Completion: May 6, 2019
• Last Updated: October 6, 2020

Record last verified: 2018-10

Locations

GB (1)