TetraSOD® Supplementation and Skeletal Muscle Redox Gene Expression

NCT06822556 | Completed

• 1 other identifier: 2021-6116-5434
• 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 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

Outcome Measures

Primary Outcomes (1)

• 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.

  The primary outcome will be assessed at the end of the 14 day placebo and 14 day Tetraselmis chuii supplementation arms

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo supplementation

Dietary Supplement: Placebo

Tetraselmis chuii

ACTIVE COMPARATOR

Tetraselmis chuii supplementation

Dietary Supplement: Tetraselmis chuii

Interventions

Placebo DIETARY_SUPPLEMENT

14 days of supplementation with 25 mg/day hemicellulose crystalline

Placebo

Tetraselmis chuii DIETARY_SUPPLEMENT

14 days of supplementation with 25 mg/day tetraselmis chuii

Tetraselmis chuii

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Loughborough University

Loughborough, United Kingdom, LE11 3TU, United Kingdom

Location

Study Officials

• Stephen 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: Dr

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 12, 2025
• Study Start: November 5, 2021
• Primary Completion: August 3, 2022
• Study Completion: October 30, 2023
• Last Updated: February 12, 2025

Record last verified: 2024-12

Locations

GB (1)