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

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

Interventions

DIETARY_SUPPLEMENT

500mg of Aronox® >40% polyphenol aronia extract

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

OTHER

Placebo

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

Sponsors & Collaborators

• Naturex

  collaborator OTHER

• Northumbria University

  lead OTHER

Principal Investigators

• Glyn Howatson · Northumbria University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

MALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-04-04

Primary Completion

2019-02-15

Completion

2019-05-06

Countries

• United Kingdom

Study Locations