PlaceboNCT06822556
TetraSOD® Supplementation and Skeletal Muscle Redox Gene Expression
A study testing Tetraselmis chuii in people with Placebo and Tetraselmis Chuii, run by Loughborough University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Placebo, Tetraselmis Chuii
- What is being tested?
- Tetraselmis chuii
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2021to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 VO2max 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)
Show all 10Show fewer
- 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
Who cannot join
- Female
- Aged <18 and >40 years old
- Sedentary or highly trained with a respective V#O2max 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)
Show all 30Show fewer
- 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
- Participants will be excluded from the biopsy sub-set if they report any of the following:
- Allergy to Lidocaine or any of the ingredients. Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, or other parts of the body, rash, itching or hives on the skin.
- Infection or swelling where the injection will be given
- Blood infections or disorders
- In severe shock
- Low blood pressure
- Disease of the brain or spinal cord
- Sudden frequent episodes of loss of consciousness
- Myasthenia gravis, a severe muscle weakness
- Heart problems
- Furthermore, Lidocaine injection will NOT be used in cases of:
- Severely disturbed cardiac conduction
- Bradycardia
- ADAMS-STOKES syndrome
- Wolfe Parkinson White syndrome
- Sudden heart failure
- Hypersensitivity to amide-type local anaesthetics
- Suspicion of hereditary tendency to malignant hyperthermia
- Disorders of blood coagulation
- Infection of the region to be injected
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Loughborough University
Loughborough, United Kingdom, LE11 3TU
About this study
Official title: The Effect of TetraSOD® Supplementation on Oxidative Stress Biomarkers, Metabolism and Endurance Exercise Performance in Healthy Adult Males
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 human skeletal muscle antioxidant gene expression is less clear.
This study assessed the effect of short-term TetraSOD supplementation on human skeletal muscle antioxidant gene expression in healthy adults.
Read the 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 on human skeletal muscle antioxidant gene expression is less clear.
This study assessed the effect of short-term TetraSOD supplementation on human skeletal muscle antioxidant gene expression in healthy adults.
- Conditions
- Placebo, Tetraselmis Chuii
- Being tested
- Placebo, Tetraselmis chuii
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
14 days of supplementation with 25 mg/day hemicellulose crystalline
Tetraselmis chuiiDietary supplement
14 days of supplementation with 25 mg/day tetraselmis chuii
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo supplementation Receives: Dietary Supplement: Placebo |
| Tetraselmis chuii | Active comparator | Tetraselmis chuii supplementation Receives: Dietary Supplement: Tetraselmis chuii |
What is being measured
The primary outcome is the main question the study is designed to answer.
Redox and antioxidant gene expression
112 genes linked to redox and antioxidant responses are expressed as fold-change gene expression (fold-change) determined using the 2-ΔΔCq method.
Measured: The primary outcome will be assessed at the end of the 14 day placebo and 14 day Tetraselmis chuii supplementation arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start5 Nov 2021
- Primary completion3 Aug 2022
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlaceboStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment 13 participants completed 2 experimental conditions in a randomized order.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- Fitoplancton Marino, S.L.
- Responsible party
- Principal investigator, Stephen Bailey, Loughborough University
- Investigators
- Stephen Bailey, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822556
- Sponsor's protocol ID
- 2021-6116-5434
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of TetraSOD® Supplementation on Oxidative Stress Biomarkers, Metabolism and Endurance Exercise Performance in Healthy Adult Males
- ClinicalTrials.gov ID
- NCT06822556
- Acronym / sponsor ID
- 2021-6116-5434
- Conditions
- Placebo, Tetraselmis Chuii
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Loughborough UniversityUniversity, hospital or other
- Collaborators
- Fitoplancton Marino, S.L.
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 human skeletal muscle antioxidant gene expression is less clear.
This study assessed the effect of short-term TetraSOD supplementation on human skeletal muscle antioxidant gene expression 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 on human skeletal muscle antioxidant gene expression is less clear.
This study assessed the effect of short-term TetraSOD supplementation on human skeletal muscle antioxidant gene expression in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Crossover Assignment 13 participants completed 2 experimental conditions in a randomized order.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplementation |
| Tetraselmis chuii | Active comparator | Dietary Supplement: Tetraselmis chuiiTetraselmis chuii supplementation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 VO2max 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
Key exclusion criteria (30 listed)
- Female
- Aged <18 and >40 years old
- Sedentary or highly trained with a respective V#O2max 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo14 days of supplementation with 25 mg/day hemicellulose crystalline | Dietary supplement | Placebo |
| Tetraselmis chuii14 days of supplementation with 25 mg/day tetraselmis chuii | Dietary supplement | Tetraselmis chuii |
Primary outcome
Redox and antioxidant gene expression
Time frame: The primary outcome will be assessed at the end of the 14 day placebo and 14 day Tetraselmis chuii supplementation arms
112 genes linked to redox and antioxidant responses are expressed as fold-change gene expression (fold-change) determined using the 2-ΔΔCq method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Bailey principal investigator
Loughborough University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetraselmis chuii in people with Placebo and Tetraselmis Chuii, run by Loughborough University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Redox and antioxidant gene expression (time frame: The primary outcome will be assessed at the end of the 14 day placebo and 14 day Tetraselmis chuii supplementation arms). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.