TetraSOD® Supplementation and Skeletal Muscle Redox Gene Expression

NCT ID: NCT06822556

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-05
• Study Completion Date: 2023-10-30

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 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.

Conditions

Placebo; Tetraselmis Chuii

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo supplementation

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

14 days of supplementation with 25 mg/day hemicellulose crystalline

Tetraselmis chuii

Tetraselmis chuii supplementation

Group Type: ACTIVE_COMPARATOR

Tetraselmis chuii

Intervention Type: DIETARY_SUPPLEMENT

14 days of supplementation with 25 mg/day tetraselmis chuii

Interventions

Placebo

14 days of supplementation with 25 mg/day hemicellulose crystalline

Intervention Type: DIETARY_SUPPLEMENT

Tetraselmis chuii

14 days of supplementation with 25 mg/day tetraselmis chuii

Intervention Type: DIETARY_SUPPLEMENT

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 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)
• 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 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)
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fitoplancton Marino, S.L.

INDUSTRY

Sponsor Role: collaborator

Loughborough University

OTHER

Sponsor Role: lead

Responsible Party

Stephen Bailey

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Bailey

Role: PRINCIPAL_INVESTIGATOR

Loughborough University

Locations

Loughborough University

Loughborough, United Kingdom, United Kingdom

Countries

United Kingdom

Other Identifiers

2021-6116-5434

Identifier Type: -

Identifier Source: org_study_id