Impact of astaxanthin on health and performance among firefighters

ISRCTN ISRCTN10901752
DOI https://doi.org/10.1186/ISRCTN10901752
ClinicalTrials.gov (NCT) Nil known
Clinical Trials Information System (CTIS) Nil known
Protocol serial number IRB2020-1379F
Sponsor Texas A&M University
Funder AstaReal Inc.
Submission date
02/10/2023
Registration date
19/10/2023
Last edited
02/12/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Astaxanthin is an antioxidant, which has been suggested to have a better antioxidant capacity. Studies with astaxanthin have shown reductions in inflammation and oxidative stress in addition to improvements in fat utilization for energy. Firefighters are exposed to various physical and psychological stressors that have been shown to increase their high risk of heart disease. Given the benefits of astaxanthin, firefighters might benefit from supplementation. The purpose of this study is to examine the effects of 4 weeks of 12 mg/day supplementation with AstaReal(R) Astaxanthin on markers of oxidative stress and inflammation in addition to the effects on substrate oxidation rates and firefighter task-specific performance.

Who can participate?
Healthy, career firefighters aged 18 - 60 years old.

What does the study involve?
Supplementation with either 12 mg/day natural astaxanthin from algae or placebo softgels for 4 weeks, followed by 2-week washout and another course of 4 weeks with either astaxanthin or placebo.

What are the possible benefits and risks of participating?
Possible benefits include improved antioxidant capacity, improved physical performance and endurance, reduced physical fatigue, improved cardiovascular health.

There are no known side effects of astaxanthin supplementation.

Where is the study run from?
Texas A&M University (USA)

When is the study starting and how long is it expected to run for? (what are the overall start and end dates?)
July 2021 to October 2022

Who is funding the study?
AstaReal Inc. (USA), a wholly owned subsidiary of Fuji Chemical Industries Co., Ltd. (Japan)

Who is the main contact?
Dr Karen Hecht, khecht@astarealusa.com

Contact information

Mr Drew Gonzales
Scientific

1112 TAMU
College Station
77843
United States of America

+1 979-458-1741
dg18@tamu.edu
Dr Richard Kreider
Principal investigator

1112 TAMU
College Station
77843
United States of America

+1 979-458-1741
rbkreider@tamu.edu
Dr Karen Hecht
Public

3 Terri Ln.
Unit #12
Burlington
08016
United States of America

+1 2067714407
khecht@astarealusa.com

Study information

Primary study designInterventional
Study designSingle-center interventional randomized double-blind placebo-controlled crossover trial
Secondary study designRandomised cross over trial
Study type Participant information sheet
Scientific titleImpact of astaxanthin supplementation on markers of cardiometabolic health and tactical performance among firefighters
Study objectives12 mg/d for four weeks of astaxanthin supplementation improves markers of oxidative stress, inflammation, cardiometabolic health, cardiorespiratory fitness, and occupational performance in career firefighters.
Ethics approval(s)

Approved 16/07/2021, TAMU IRB (1112 TAMU, College Station, 77843, United States of America; +1 979.458.4067; irb@temu.edu), ref: IRB2020-1379F

Health condition(s) or problem(s) studiedCardiovascular health and athletic performance
InterventionRandomized Latin Square Design
Crossover study given 12mg astaxanthin for 4 weeks, 2 weeks washout then 4 weeks placebo OR placebo for 4 weeks, 2 weeks washout then 4 weeks 12mg astaxanthin.
Intervention typeSupplement
Primary outcome measure(s)

1. Fasting blood advanced oxidation protein products, advanced glycated end products, and adiponectin were measured to assess oxidative stress via enzyme-linked immunosorbent assays following 28 days of supplementation with astaxanthin or placebo.
2. Fasting blood granulocyte-macrophage colony-stimulating factor [GM-CSF], interferon-gamma [IFN-γ], tumor necrosis factor-alpha [TNF-α], Interleukin[IL]-1β, IL-2, IL-4, IL-5, IL-6, IL-8, and IL-10 were measured to assess inflammation via Luminex multiplex assays pre- and post-exercise following 28 days of supplementation with astaxanthin or placebo.
3. Fasting blood lipids profiles (i.e., total cholesterol, high-density lipoprotein, low-density lipoprotein, non-high-density lipoprotein cholesterol, very-low-density lipoprotein cholesterol, low-density lipoprotein / high-density lipoprotein ratio, total cholesterol/ high-density lipoprotein ratio, and triglycerides) were measured to assess cardiometabolic health status pre- and post-exercise following 28 days of supplementation with astaxanthin or placebo.
4. Ventilatory anaerobic threshold, peak oxygen consumption, substrate oxidation rates, and time-to-exhaustion were measured to assess cardiorespiratory fitness by analyzing breath-by-breath volumes of oxygen consumption and carbon dioxide production on an incremental exercise stress test with a metabolic cart following 28 days of supplementation with astaxanthin or placebo.
5. Salivary cortisol, uric acid, and interleukin-1β were measured to assess the inflammatory and oxidative stress response to firefighter activities via enzyme-linked immunosorbent assays on post-supplementation salivary samples collected at pre- and post-firefighter-specific task assessment. The time points collected were 30 minutes and 5 minutes prior to the firefighter assessment, as well as 5 minutes and 3 minutes after the firefighter assessment following 28 days of supplementation with astaxanthin or placebo.
6. Time to complete, heart rate responses, and air utilization were measured to assess occupational performance before, during, and after the firefighter activities. Time to completion on the firefighter task assessment was noted as the total time it took to complete the battery of tasks; heart rate responses for the firefighter assessment were taken before, average during, and after the assessment; air utilization was assessed after the assessment by measuring pre- and post-assessment air tank pounds per square inch measurements following 28 days of supplementation with astaxanthin or placebo.

Key secondary outcome measure(s)

1. Fasting blood whole blood cell count (e.g., white blood cell count, red blood cell count, hemoglobin, hematocrit, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, red blood cell distribution width, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), liver function markers (e.g., alkaline phosphatase, aspartate transaminase, alanine transaminase, total protein, albumin, globulin, albumin/globulin ratio, bilirubin), and renal function markers (e.g., glucose, sodium, potassium, chloride, carbon dioxide, calcium, blood urea nitrogen, creatinine, blood urea nitrogen/creatinine ratio, non-African American estimated glomerular filtration rate) were measured to assess clinical health and safety pre- and post-exercise following 28 days of supplementation with astaxanthin or placebo.
2. Body fat percentage was measured using a dual x-ray absorptiometry scan following 28 days of supplementation with astaxanthin or placebo.
3. Height and weight were measured using a Health-O-Meter Professional 500KL self-calibrating digital scale following 28 days of supplementation with astaxanthin or placebo. Furthermore, height and weight were used to calculate body mass index following 28 days of supplementation with astaxanthin or placebo.
4. Resting heart rate and blood pressure measurements were assessed via an automatic blood pressure monitor following 28 days of supplementation with astaxanthin or placebo.
5. Subjective stress was measured using the firefighter self-efficacy coping questionnaire following 28 days of supplementation with astaxanthin or placebo.
6. Perceived adverse effects were measured via the side effects questionnaire following 28 days of supplementation with astaxanthin or placebo.

Completion date29/10/2022

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexMale
Target sample size at registration15
Total final enrolment20
Key inclusion criteria1. They have a willingness to provide voluntary, written, informed consent to participate in the study;
2. They are healthy professional or volunteer male firefighters age 18 - 60 years;
3. They are free from any signs, symptoms, or diagnosis of any cardio-respiratory and/or metabolic disorders;
4. They are free from any known blood disorders (e.g., anemia, hemophilia);
5. They are free from any caffeinated supplements (e.g., thermogenics, pre-workouts, energy drinks, etc) consumption 24-hours prior to all testing sessions;
6. They are free from any alcohol and/or nicotine consumption 24-hours prior to all testing sessions;
7. They are free from ergogenic aids like creatine or testosterone boosters for at least two weeks prior to the initiation of the study;
8. They are resistance trained defined as participating in regular resistance training exercises for at least twice per week for the last six months;
9. They have no current or previous musculoskeletal injuries within the last year;
10. They are engaged in at least 150-minutes of moderate - intensity exercise per week for the last six months;
11. They do not have any known allergies to sunflower oil.
Key exclusion criteria1. They use prescription or over-the-counter (OTC) products known to interact with astaxanthin within 72 hours of randomization and during the trial such as aspirin, clopidogrel and nonsteroidal anti-inflammatory drugs (NSAIDs);
2. They have any known allergies to sunflower oil or astaxanthin;
3. They are not resistance trained and defined by participating in regular resistance training exercises for at least twice per week for the last six months;
4. They are not engaged in 150-minutes of moderate - intensity exercise each week for the last six months;
5. They have any medical condition that would affect the ability to perform a standard exercise program;
6. They are a current smoker (cigarettes)
Date of first enrolment01/01/2022
Date of final enrolment15/08/2022

Locations

Countries of recruitment

  • United States of America

Study participating centre

Texas A&M University
College Station
77843
United States of America

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available due to confidentiality.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 20/11/2024 02/12/2024 Yes No
Abstract results p. 9 27/07/2023 03/10/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

02/12/2024: Publication reference added.
04/10/2023: Trial's existence confirmed by Texas A&M.

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