TetraSOD® Supplementation and Exercise Performance

NCT06831656 | Completed

• 1 other identifier: R19-P160
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Microalgae; Endurance performance

Outcome Measures

Primary Outcomes (2)

• Time to exhaustion during a severe-intensity cycle ergometry test continued until exhaustion

  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

  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 Outcomes (2)

• End-exercise blood lactate concentration during a severe-intensity cycle ergometry test continued until exhaustion

  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

  One assessment prior to and 14 days following the placebo supplementation, and one assessment prior to and 14 days following Tetraselmis chuii supplementation

Study Arms (4)

Placebo-Pre

OTHER

No supplementation prior to undergoing the placebo supplement

Other: Placebo-Pre

Placebo-post

PLACEBO COMPARATOR

Placebo supplementation

Dietary Supplement: Placebo-Post

Tetraselmis chuii-Pre

OTHER

No supplementation prior to undergoing the Tetraselmis chuii supplement

Other: Tetraselmis chuii-Pre

Tetraselmis chuii-Post

ACTIVE COMPARATOR

Tetraselmis chuii supplementation

Dietary Supplement: Tetraselmis chuii-Post

Interventions

Placebo-Pre OTHER

No dietary supplementation prior to undergoing the placebo supplement

Placebo-Pre

Placebo-Post DIETARY_SUPPLEMENT

14 days of supplementation with 25 mg/day hemicellulose crystalline

Placebo-post

Tetraselmis chuii-Pre OTHER

No dietary supplementation prior to undergoing the tetraselmis chuii supplement

Tetraselmis chuii-Pre

Tetraselmis chuii-Post DIETARY_SUPPLEMENT

14 days of supplementation with 25 mg/day tetraselmis chuii

Tetraselmis chuii-Post

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loughborough University: lead
• Fitoplancton Marino, S.L.: collaborator

Study Sites (1)

Loughborough University

Loughborough, Leicestershire, LE7 7WG, United Kingdom

Location

Study Officials

• Stephen J Bailey

  Loughborough University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Funder
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader in Human and Exercise Physiology

Model Details: Crossover Assignment 13 participants completed 2 experimental conditions in a randomized order.

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: February 18, 2025
• Study Start: October 4, 2019
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: February 18, 2025

Record last verified: 2024-12

Locations

GB (1)