TetraSOD® Supplementation and Exercise Performance
February 15, 2025 updated by: Stephen Bailey, Loughborough University
The Effect of TetraSOD® Supplementation on Blood Oxidative Stress Biomarkers and Endurance Exercise Performance in Healthy Adults
Tetraselmis chuii (TetraSOD) is a marine microalgae that has been reported to improve antioxidant responses in human skeletal muscle cells treated with TetraSOD and to improve recovery from muscle damaging exercise in humans supplemented with TetraSOD.
However, the effects of TetraSOD supplementation on endurance performance and physiology is less clear.
This study assessed the effect of short-term TetraSOD supplementation on endurance performance and physiology in healthy adults.
Study Overview
Status
Completed
Detailed Description
It is well documented that the production of reactive oxygen species (ROS; unstable molecules that react easily with and damage other molecules in a cell) increases in-line with the intensity and duration of exercise . Although increased ROS production during exercise is initially managed by a variety of 'antioxidants', continued ROS production exceeds the capacity of this antioxidant defense system leading to the development of oxidative stress and impaired exercise performance. Therefore, interventions that can lessen exercise-induced oxidative stress have the potential to improve exercise performance. While dietary supplementation with antioxidant vitamins (e.g. vitamin C and E) has this potential, such interventions do not typically improve exercise performance.
Therefore, further research is required to investigate the potential for novel nutritional supplements to lessen exercise-induced oxidative stress and to improve exercise performance.
Tetraselmis chuii (TetraSOD) is a natural marine microalgae product. Recent preliminary evidence suggests that treating human skeletal muscle cells with TetraSOD can increase the production of antioxidant enzymes to limit oxidative stress development. In addition, TetraSOD supplementation has been reported to improve recovery from muscle damaging exercise. However, the effects of TetraSOD supplementation on endurance performance and physiology is less clear.
The purpose of this study was to assess the effect of short-term TetraSOD supplementation on endurance performance and physiology in healthy adults.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Leicestershire
-
Loughborough, Leicestershire, United Kingdom, LE7 7WG
- Loughborough University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy male (as determined by the Health Screening Questionnaire)
- Adult (aged ≥18 and ≤40 years old)
- Recreationally-active (≥2 and ≤4 exercise sessions per week) and a V̇O2max of ≥ 35 mL/kg/min and ≤ 65 mL/kg/min as determined from the preliminary exercise test
- No known history of gastric, digestive, cardiovascular, renal disease or any other orthopaedic diseases related to motor organs
- Non-smoker
- Healthy body mass index (BMI; ≥18.5 and ≤24.9 kg/m2)
- Not using any dietary supplements, including antioxidant and nitrate-rich supplements, currently or in the past one month
- Not a heavy drinker (≤ 14 units of alcohol) on most weeks
- Not using medication that may affect study measures
- Not participating in other studies currently or in the past two months prior to the consenting session (visit 1) or having an intention to participate in other studies over the period of this study
Exclusion Criteria:
- Female
- Aged <18 and >40 years old
- Sedentary or highly trained with a respective V̇O2max of < 35 mL/kg/min and > 65 mL/kg/min as determined from the preliminary exercise test
- History of gastric, digestive, cardiovascular, renal disease or any other orthopaedic diseases related to motor organs
- Smoker
- Unhealthy body mass index (BMI;<18.5 and >24.9 kg/m2)
- Using any dietary supplements, including antioxidant and nitrate-rich supplements, currently or in the past one month
- Heavy drinker (> 14 units of alcohol) on most weeks
- Using medication that may affect study measures
- Participating in other studies currently or in the past two months prior to the consenting session (visit 1) or having an intention to participate in other studies over the period of this study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Placebo-Pre
No supplementation prior to undergoing the placebo supplement
|
No dietary supplementation prior to undergoing the placebo supplement
|
|
Placebo Comparator: Placebo-post
Placebo supplementation
|
14 days of supplementation with 25 mg/day hemicellulose crystalline
|
|
Other: Tetraselmis chuii-Pre
No supplementation prior to undergoing the Tetraselmis chuii supplement
|
No dietary supplementation prior to undergoing the tetraselmis chuii supplement
|
|
Active Comparator: Tetraselmis chuii-Post
Tetraselmis chuii supplementation
|
14 days of supplementation with 25 mg/day tetraselmis chuii
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to exhaustion during a severe-intensity cycle ergometry test continued until exhaustion
Time Frame: One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
|
Time to exhaustion during severe-intensity cycle ergometry measured in seconds
|
One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
|
|
End-exercise pulmonary oxygen uptake during a severe-intensity cycle ergometry test continued until exhaustion measured using an online gas analyser
Time Frame: One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
|
Pulmonary oxygen uptake at the end of a severe-intensity cycling bout completed until exhaustion to provide an estimate of VO2max measured in L/min using a breath-by-breath gas exchange analyzer and taken as the mean over the final 30 s of the test.
|
One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
End-exercise blood lactate concentration during a severe-intensity cycle ergometry test continued until exhaustion
Time Frame: One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
|
Blood lactate concentration at the end of a severe-intensity cycling bout continued until exhaustion measured in mmol/L using an autoanalyzer
|
One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
|
|
End-exercise rating of perceived exertion using the Borg 6-20 scale during a severe-intensity cycle ergometry test continued until exhaustion
Time Frame: One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
|
Assessment of rating of perceived exertion at the end of a severe-intensity cycling bout completed until exhaustion using the Borg 6-20 scale where 6 = no exercise and 20 = maximal exertion with measurement units of arbitrary units.
|
One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen J Bailey, Loughborough University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 4, 2019
Primary Completion (Actual)
May 19, 2021
Study Completion (Actual)
May 19, 2021
Study Registration Dates
First Submitted
December 31, 2024
First Submitted That Met QC Criteria
February 15, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 15, 2025
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R19-P160
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.