TetraSOD® Supplementation and Exercise Performance

NCT ID: NCT06831656

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-04

Study Completion Date

2021-05-19

Brief Summary

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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

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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.

Conditions

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Placebo-Pre Placebo-Post Tetraselmis Chuii-Pre Tetraselmis Chuii-Post

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assignment 13 participants completed 2 experimental conditions in a randomized order.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Funder

Study Groups

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Placebo-Pre

No supplementation prior to undergoing the placebo supplement

Group Type OTHER

Placebo-Pre

Intervention Type OTHER

No dietary supplementation prior to undergoing the placebo supplement

Placebo-post

Placebo supplementation

Group Type PLACEBO_COMPARATOR

Placebo-Post

Intervention Type DIETARY_SUPPLEMENT

14 days of supplementation with 25 mg/day hemicellulose crystalline

Tetraselmis chuii-Pre

No supplementation prior to undergoing the Tetraselmis chuii supplement

Group Type OTHER

Tetraselmis chuii-Pre

Intervention Type OTHER

No dietary supplementation prior to undergoing the tetraselmis chuii supplement

Tetraselmis chuii-Post

Tetraselmis chuii supplementation

Group Type ACTIVE_COMPARATOR

Tetraselmis chuii-Post

Intervention Type DIETARY_SUPPLEMENT

14 days of supplementation with 25 mg/day tetraselmis chuii

Interventions

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Placebo-Pre

No dietary supplementation prior to undergoing the placebo supplement

Intervention Type OTHER

Placebo-Post

14 days of supplementation with 25 mg/day hemicellulose crystalline

Intervention Type DIETARY_SUPPLEMENT

Tetraselmis chuii-Pre

No dietary supplementation prior to undergoing the tetraselmis chuii supplement

Intervention Type OTHER

Tetraselmis chuii-Post

14 days of supplementation with 25 mg/day tetraselmis chuii

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fitoplancton Marino, S.L.

INDUSTRY

Sponsor Role collaborator

Loughborough University

OTHER

Sponsor Role lead

Responsible Party

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Stephen Bailey

Reader in Human and Exercise Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen J Bailey

Role: PRINCIPAL_INVESTIGATOR

Loughborough University

Locations

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Loughborough University

Loughborough, Leicestershire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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R19-P160

Identifier Type: -

Identifier Source: org_study_id

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