To Assess the Influence of Aronox on Parameters Associated With Recovery Following Muscle Damaging Exercise

NCT03696238 | Completed

• 1 other identifier: NUAR01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, double blind, counterbalanced, placebo controlled independent groups design. Prior to the visit, participants will be given a participant information sheet to inform of the procedure and requirements and undergo initial screening via email or telephone to ascertain suitability to participate. Stature, body mass, blood pressure and heart rate will be assessed. Participants will then be familiarized with the performance tests (MVC, vertical jump and sprint performance) and randomized to an investigational product group (2 groups: Aronox vs placebo; 1:1 allocation). The first investigational dose 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 asked to keep a food and activity diary for the 3 days preceding the baseline visit and for the duration of the damaging-recovery protocol. Following this supplementation period (28 days), participants will be asked to return to the lab in a fed (not less than 2 hours prior to the visit) and hydrated state. Participants will also be asked to abstain from strenuous exercise and caffeine for 24 h prior to each lab visit. Stature, body mass, blood pressure and heart rate will be assessed. This will be followed by baseline assessment of muscle damage which will consist of visual analogue scales to assess lower limb muscle soreness (DOMS); pain pressure threshold and baseline measures of functional performance (maximal voluntary contraction, vertical jump performance and sprint performance) and limb girth. Furthermore, a blood sample will be taken to analyze creatine kinase (index of muscle damage). This will be followed by a strenuous bout of exercise designed to cause muscle damage comprising of 100 drop jumps from a 0.6 m platform at a rate of 1 jump every 10 seconds. A short rest will be provided after every 20 jumps. Each jump is performed by the participant stepping from the platform and landing two-footed on the floor and descending quickly to \~90° and 'explosively jumping upward with maximum effort. This model for muscle damage has been used on numerous occasions in the literature and has been used with great success in our own laboratory. Participants will then return to the lab at 24, 48 and 72 h post damaging protocol where muscle damage measures will be repeated to assess the level of recovery between the groups.

Conditions

Muscle Damage

Outcome Measures

Primary Outcomes (1)

• Change in Muscle strength

  Muscle strength will be measured via maximal isometric voluntary contractions (MIVCs) performed using a portable strain gauge (MIE Medical Research Ltd., Leeds, UK). The peak value from 3 maximal contractions (separated by 60 seconds) will be used for analysis.

  baseline, 24, 48 and 72 hours post exercise

Secondary Outcomes (6)

• Change in passive muscle soreness

  baseline, 24, 48 and 72 hours post exercise

• Change in limb girth

  baseline, 24, 48 and 72 hours post exercise

• Change in creatine kinase

  baseline, 24, 48 and 72 hours post exercise

• Change in counter movement jump height

  baseline, 24, 48 and 72 hours post exercise

• Change in 30m sprint time

  baseline, 24, 48 and 72 hours post exercise

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

You may qualify if:

• Healthy men 18-35 years of age
• Free from musculoskeletal injury
• Do not participate in more than 4 hour of vigorous exercise per week
• Not taking dietary supplement or pre workout supplements for at least 1 month prior to study start
• Can abstain from other exercise for the duration of damage part of the study (4 days)
• Willing to participate and adhere to the study protocol
• Willing to limit berry and/or cherry intake to one portion per day
• Not to change their dietary / workout habits throughout the study (apart from abstaining from exercise during the damage part of the study)
• Able to understand the participant information, health screening questionnaire and the informed consent information
• Willing to participate and sign the informed consent form

You may not qualify if:

• BMI ≥30
• 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
• Subject has a significant history or current presence of treated or untreated cardiometabolic, gastrointestinal, bleeding disorder, diabetes mellitus, high blood pressure (BP) \[systolic BP\> 140 and/or diastolic BP\> 90\], thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
• Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
• Have a recent history of surgery that might affect physical performance
• Current smoker
• Significant 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
• Givaudan France Naturals: collaborator

Study Sites (1)

Northumbrai University

Newcastle upon Tyne, 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: September 25, 2018
• First Posted: October 4, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: May 31, 2019
• Last Updated: October 6, 2020

Record last verified: 2018-09

Locations

GB (1)