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Completed

NCT Number: NCT06831656

TetraSOD® Supplementation and Exercise Performance

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, Leicestershire, LE7 7WG, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo-Pre

Other

No dietary supplementation prior to undergoing the placebo supplement

Placebo-Post

Dietary Supplement

14 days of supplementation with 25 mg/day hemicellulose crystalline

Tetraselmis chuii-Pre

Other

No dietary supplementation prior to undergoing the tetraselmis chuii supplement

Tetraselmis chuii-Post

Dietary Supplement

14 days of supplementation with 25 mg/day tetraselmis chuii

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Collaborators

  • Fitoplancton Marino, S.L.

Registry information

Official study title

The Effect of TetraSOD® Supplementation on Blood Oxidative Stress Biomarkers and Endurance Exercise Performance in Healthy Adults

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.