Oxidative Stress Clinical Trial
Official title:
Investigating the Impact of a Natural Antioxidant Food Product on Exerciseinduced Oxidative Stress in Recreationally Active Participants
NCT number | NCT04959006 |
Other study ID # | R9039 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | October 1, 2021 |
Verified date | February 2022 |
Source | Anglia Ruskin University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | October 1, 2021 |
Est. primary completion date | September 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Anglia Ruskin University | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Anglia Ruskin University |
United Kingdom,
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oxidative stress biomarker | Blood measure of malondialdehyde, MDA (pmol/ml) | Change from pre (day 1) to post intervention (day 18) | |
Primary | 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) | |
Primary | Endogenous antioxidant enzyme 1 | Blood measure of catalase (mU/ml) | Relative change from pre (day 1) to post intervention (day 18) | |
Primary | Endogenous antioxidant enzyme 2 | Blood measure of superoxide dismutase (inhibition rate %) | Relative change from pre (day 1) to post intervention (day 18) | |
Primary | 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 | Submaximal exercise respiratory measures | Assessment of metabolic efficiency via respiratory measures (oxygen, carbon dioxide, both measured in L/min) during steady state exercise | Relative change from pre (day 1) to post intervention (day 18) | |
Secondary | Maximal exercise respiratory measures | Assessment of exercise capacity and tolerance during maximal exercise via respiratory measures (oxygen, carbon dioxide, both measured in L/min) | Relative change from pre (day 1) to post intervention (day 18) | |
Secondary | Body mass | Assessment of body mass (kg). Body mass and height will be combined to report Body Mass Index (BMI) in kg/m^2 | Change from pre (day 1) to post intervention (day 18) | |
Secondary | Height | Assessment of participant height (m). Body mass and height will be combined to report Body Mass Index (BMI) in kg/m^2 | Change from pre (day 1) to post intervention (day 18) | |
Secondary | Body composition | Assessment of bodyfat (%) used to derive lean mass (kg) based on total body mass (kg) | Change from pre (day 1) to post intervention (day 18) | |
Secondary | Blood pressure | Assessment of systolic and diastolic blood pressure (measured in mmHg) at rest | Change from pre (day 1) to post intervention (day 18) |
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