Investigating a Natural Antioxidant Food Product on Oxidative Stress in Recreationally Active Participants

NCT04959006 | Completed

• 1 other identifier: R9039
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the short term use of olive extract polyphenols on markers of oxidative stress in response to acute endurance exercise in recreationally active, healthy volunteers.The study will be conducted under laboratory conditions following a 16 day supplemental period. Participants will be required to attend the laboratory for a pre-screening/familiarisation trial followed by assessments PRE (baseline, days 1,2) and POST intervention (days 18,19). Across the intervention, participants will maintain habitual dietary intake/ exercise training. Additionally participants will be randomised in a double-blinded manner to either a placebo or antioxidant-rich supplementation (olive extract water). It is hypothesised that the polyphenols (antioxidants) found within olive extract drink will enhance markers of recovery to an endurance exercise bout compared with the placebo drink.

Conditions

Oxidative Stress; Exercise Recovery

Keywords

Antioxidants; Exercise Metabolism; Exercise Nutrition

Outcome Measures

Primary Outcomes (5)

• Oxidative stress biomarker

  Blood measure of malondialdehyde, MDA (pmol/ml)

  Change from pre (day 1) to post intervention (day 18)

• Redox status

  Blood measure of reduced glutathione (GSH) to oxidized glutathione (GSSG) (measured in uM)

  Relative change from pre (day 1) to post intervention (day 18)

• Endogenous antioxidant enzyme 1

  Blood measure of catalase (mU/ml)

  Relative change from pre (day 1) to post intervention (day 18)

• Endogenous antioxidant enzyme 2

  Blood measure of superoxide dismutase (inhibition rate %)

  Relative change from pre (day 1) to post intervention (day 18)

• Hydroxytyrosol

  Blood measure of hydroxytyrosol (main active ingredient in the antioxidant supplementation, measured in ng/ml)

  Overall change from pre (day 1) to post intervention (day 18)

Secondary Outcomes (6)

• Submaximal exercise respiratory measures

  Relative change from pre (day 1) to post intervention (day 18)

• Maximal exercise respiratory measures

  Relative change from pre (day 1) to post intervention (day 18)

• Body mass

  Change from pre (day 1) to post intervention (day 18)

• Height

  Change from pre (day 1) to post intervention (day 18)

• Body composition

  Change from pre (day 1) to post intervention (day 18)

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

Placebo drink - oral bolus (25ml) - colour/taste matched (prune juice/cola/tonic water, 1:1:1 ratio).

Dietary Supplement: Placebo

Antioxidant supplement

EXPERIMENTAL

Experimental condition -oral bolus (25ml) olive extract drink(https://www.oliphenolia.it/uk/)

Dietary Supplement: Antioxidant supplement

Interventions

Antioxidant supplement DIETARY_SUPPLEMENT

Short term (16d) supplementation of either the antioxidant supplement (Oliphenolia) or placebo. Participants required to consume 2x25ml drinks, one mid-morning, one mid-afternoon between meals.

Also known as: Oliphenolia

Antioxidant supplement

Placebo DIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, UK based, above 21 years of age and below 65 years of age
• All participants: No known history (including family history) of heart abnormalities, hypertension, coronary heart disease or diabetes (determined from pre-study health screen questionnaire)
• All participants: Not currently suffering from any musculo-skeletal injury, or any other reason that may prevent participation in cardiovascular exercise
• All participants: Have not suffered from recent viral infections ie: influenza (defined within the prior 2 months)
• All participants (and household members): COVID-19 related - have not suffered with any symptoms associated with Covid-19
• All participants: Not suffering from any known blood related disorders, including blood coagulation abnormalities, or have any adverse reactions to blood taking
• All participants: Not taking any prescribed or over-the-counter medication which may influence exercise training (with the exception of inhalers for exercise induced asthma or contraceptive pill)
• All participants: Not consuming or prepared to refrain from consumption, any commercial supplementation which conflicts with the study parameters ie: antioxidants.
• All participants: no known allergy or intolerance to olives or prune/grape juice.
• Baseline maximal oxygen uptake \>25ml/kg/min representative of normal fitness levels (measured during pre-screening)

You may not qualify if:

• Anyone below the age of 21 years or above 65 years of age
• All participants: anyone with a known history (including family history) of heart abnormalities, hypertension, coronary heart disease or diabetes (determined from pre-study health screen questionnaire)
• All participants: Anyone suffering from a current musculo-skeletal injury, or any other reason that may prevent participation in cardiovascular exercise
• All participants: those suffering from recent viral infections ie: influenza (defined within the prior 2 months)
• All participants: anyone who has (previously or currently) had any symptoms associated with covid-19 (including household members)
• All participants: Those with known blood related disorders, including blood coagulation abnormalities, or have any adverse reactions to blood taking. This includes any participant who has or potentially has an infectious disease, inc. HIV, and all types of hepatitis.
• All participants: Anyone taking any prescribed or over-the-counter medication which may influence exercise training (with the exception of inhalers for exercise induced asthma or contraceptive pill)
• All participants: Anyone consuming or not prepared to refrain from consumption, any commercial supplementation which conflicts with the study parameters ie: antioxidants
• All participants: anyone with a known allergy or intolerance to olives or prune/grape juice.
• Any not meeting the baseline criteria for maximal oxygen uptake
• FEMALE ONLY: Any participant who is, suspects they may be or becomes pregnant during the study.

Sponsors & Collaborators

• Anglia Ruskin University: lead

Study Sites (1)

Anglia Ruskin University

Cambridge, Cambridgeshire, CB1 1PT, United Kingdom

Location

Related Publications (4)

• Bowtell J, Kelly V. Fruit-Derived Polyphenol Supplementation for Athlete Recovery and Performance. Sports Med. 2019 Feb;49(Suppl 1):3-23. doi: 10.1007/s40279-018-0998-x.

  PMID: 30671906 BACKGROUND

• Fisher-Wellman K, Bloomer RJ. Acute exercise and oxidative stress: a 30 year history. Dyn Med. 2009 Jan 13;8:1. doi: 10.1186/1476-5918-8-1.

  PMID: 19144121 BACKGROUND

• Bloomer RJ, Goldfarb AH, McKenzie MJ. Oxidative stress response to aerobic exercise: comparison of antioxidant supplements. Med Sci Sports Exerc. 2006 Jun;38(6):1098-105. doi: 10.1249/01.mss.0000222839.51144.3e.

  PMID: 16775552 BACKGROUND

• James CA, Richardson AJ, Watt PW, Gibson OR, Maxwell NS. Physiological responses to incremental exercise in the heat following internal and external precooling. Scand J Med Sci Sports. 2015 Jun;25 Suppl 1:190-9. doi: 10.1111/sms.12376.

  PMID: 25943670 BACKGROUND

Study Officials

• Justin Roberts, PhD

  Anglia Ruskin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Nutritional supplements will be provided in a randomised, double-blinded manner. Both the participants and research testers will be masked from knowing the specifics of the supplement intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants randomly assigned to either placebo or antioxidant-rich olive extract in a parallel, double blind manner

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: July 12, 2021
• Study Start: May 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)