Clinical trial NCT06831656: TetraSOD® Supplementation and Exercise Performance
Official title: The Effect of TetraSOD® Supplementation on Blood Oxidative Stress Biomarkers and Endurance Exercise Performance in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placebo-Pre
Placebo-Post
Tetraselmis Chuii-Pre
Tetraselmis Chuii-Post
Keywords: Microalgae
Endurance performance
Lead sponsor: Loughborough University
Sponsor class: OTHER
Collaborators: name: Fitoplancton Marino, S.L.
First posted: 2025-02-18
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment 13 participants completed 2 experimental conditions in a randomized order.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to exhaustion during a severe-intensity cycle ergometry test continued until exhaustion
timeFrame: One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
measure: End-exercise pulmonary oxygen uptake during a severe-intensity cycle ergometry test continued until exhaustion measured using an online gas analyser
timeFrame: One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
Secondary outcomes:
measure: End-exercise blood lactate concentration during a severe-intensity cycle ergometry test continued until exhaustion
timeFrame: One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
measure: End-exercise rating of perceived exertion using the Borg 6-20 scale during a severe-intensity cycle ergometry test continued until exhaustion
timeFrame: One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: Loughborough University
state: Leicestershire
Study officials:
affiliation: Loughborough University
name: Stephen J Bailey
role: PRINCIPAL_INVESTIGATOR
References: