Healthy VolunteerNCT06593535
Evaluation of Astaxanthin Properties on Anti-fatigue
A study testing Astaxanthin (AST trial) in people with Healthy Volunteer, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Ten young, healthy, physically active male college students were crossed over for AST or placebo supplements randomized into placebo or AST trials and orally consumed placebo or AST (28 mg/d) supplements for four days. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Astaxanthin (AST trial)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jun 2022to 20 Sep 2022
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recruit people who are healthy are 20-40 years male and have exercise habits in college students
Who cannot join
- Have smoking and drinking habits.
- Those who have implanted artificial joints in the past six months and have had recent surgery.
- People who feel unwell due to other reasons during the experiment.
- Take any drugs or Nutrition supplements in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short-term Astaxanthin Supplementation Enhances Cycling Performance and Attenuates Exhaustive Exercise-induced Muscle Damage and Oxidative Stress in Young Healthy Adults: A Randomized Controlled Trial
Ten young, healthy, physically active male college students were crossed over for AST or placebo supplements randomized into placebo or AST trials and orally consumed placebo or AST (28 mg/d) supplements for four days. Short-term AST supplementation enhanced endurance performance and effectively reversed cycling challenge-induced muscle damage and lipid peroxidation.
Read the detailed description
AST is composed of two β-ionone ring systems that are linked by a polyene chain and contain oxygenated keto and hydroxyl moieties, which are responsible for its powerful antioxidant activity. AST has been shown to have numerous health benefits in humans, including improved antioxidant and inflammatory status under different stress conditions. Therefore, this study will explore AST supplement to improve exercise-induced muscle damage and/or physiological anomalies in adults. Ten physically active male adults were randomized into placebo or AST trials and consumed placebo or AST (28 mg/d) supplements orally for 4 days. On day-4, participants performed an exhaustive cycling challenge at 75% V̇O2max, and the time to exhaustion (TTE) was recorded. Blood and gaseous samples were collected before, during, and immediately after cycling to determine changes in muscle damage, inflammation, oxidative stress, and substrate utilization.
- Conditions
- Healthy Volunteer
- Being tested
- Placebo (Placebo trial), Astaxanthin (AST trial)
- Keywords
- Cycling performance, fatigue, ergogenic aids, lipid peroxidation
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Placebo trial)Other
The Placebo capsule supplement was taken for 4 days (7 capsules per day)
Astaxanthin (AST trial)Other
The AST capsule supplement was taken for 4 days, with a daily dosage of 28 mg of AST (equivalent to 7 capsules per day, each containing 4 mg of AST).
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax. Receives: Other: Placebo (Placebo trial); Other: Astaxanthin (AST trial) |
| Astaxanthin (AST) | Experimental | Each capsule containing 4 mg of AST Receives: Other: Placebo (Placebo trial); Other: Astaxanthin (AST trial) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Exhaustion Exercise
Investigators conducted a double-blind test, where volunteers' basal maximal oxygen consumption (VO2max) was measured both before the intervention. The pretest VO2max is a reference to adjust the exercise intensity for each individual. To assess exhaustive endurance, participants exercised at 75% of their VO2max, and the cycling time from the start to the point of exhaustion was recorded.
Measured: 21 days
Clinical Biochemistry of muscle damage biomarkers and blood glucose
Blood samples were collected at five different time points (one hour before (B), at the beginning (0 min), during (20 min, 40 min), and immediately (E) after the exhaustive cycling exercise challenge. Changes in blood glucose levels were estimated using blood from the fingertips via an Accu-Chek® Guide blood glucose glucometer (Roche, Mannheim, Germany). Muscle damage biomarkers, including creatine kinase (CK), lactate dehydrogenase (LDH), and uric acid (UA), were measured in the serum. The CK (EC2.7.3.2), LDH (EC 1.1.1.27), and UA (C97792) concentrations were estimated using commercial analytical reagents (Beckman Coulter). An automated clinical chemistry analyzer was used to measure CK and LDH levels on a Beckman Coulter AU5800 (Beckman Coulter Inc., CA, USA).
Measured: 21 days
Clinical Biochemistry of total antioxidant capacity and lipid peroxidation
Blood samples were collected at five different time points (one hour before (B), at the beginning (0 min), during (20 min, 40 min), and immediately (E) after the exhaustive cycling exercise challenge. The scavenging ability of antioxidants (6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid, Trolox) was determined using a curve, and the amount of Trolox equivalent to the test serum's inhibition rate was calculated. Next, the level of malondialdehyde (MDA), a standard biomarker of lipid peroxidation, was determined by an ELISA kit provided by the Caman Company (Cayman Chemical Company, Michigan, USA). As described in the protocol, the reaction mixture was boiled at 90-100°C for 60 min, and the absorbance at 550 nm was measured using an ELISA plate reader (Tecan GENios, A-5082, Austria). The values are expressed as micromoles of MDA per liter.
Measured: 21 days
Clinical Biochemistry of the inflammatory response
Blood samples were collected at five different time points (one hour before (B), at the beginning (0 min), during (20 min, 40 min), and immediately (E) after the exhaustive cycling exercise challenge. According to the manufacturer's instructions, the pro-inflammatory cytokine TNF-α was analyzed with a commercial ELISA kit (BioLegend, San Diego, CA). An enzyme immunoassay read The absorbance at 450 nm within 15 minutes (Tecan GENios, A-5082, Austria). Concentrations of C-reactive protein (CRP) were measured using a human ELISA kit (E-80CRP, Immunology Consultants Laboratory, Inc., Newberg, OR, USA). The sample absorbance was read at 450 nm within 30 min.
Measured: 21 days
Assessment of the profile of mood state (POMS)
POMS brief was chosen for this study to evaluate the mood of individuals. After the TTE, participants completed the form, and their responses were analyzed using simple statistics. The results were shown in six dimensions, one positive: (1) vigor; and five negatives: (2) tension, (3) depression, (4) anger, (5) fatigue and (6) confusion.
Measured: 21 days
Assessment of the RER, fat oxidation rate and carbohydrate oxidation rate
Ggaseous samples were collected at five different time points (one hour before (B), at the beginning (0 min), during (20 min, 40 min), and immediately (E) after the exhaustive cycling exercise challenge.The pulmonary oxygen consumption (VO2) and carbon dioxide production (VCO2) during exercise were used to determine metabolic substrate utilization. The gaseous exchange ratio during exercise reflects the relative contributions of carbohydrates and fat to energy metabolism. The RER was calculated by dividing the VCO2 value by the VO2 value (RER =(VCO2)⁄(VO2 )). The fat oxidation rate was calculated using the following equation: Fat oxidation rate=1.695×VO2-1.701×VCO2 ). Similarly, the carbohydrate oxidation rate was calculated using the following equation: Carbohydrate oxidation rate=4.585×VCO2-3.226×VO2
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Jun 2022
- Primary completion17 Jul 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Ten young healthy physically active male college students. Participants were crossed over for AST or placebo supplements, which was completed in four days. Between the crossover trials, participants had a one-week washout period to nullify the effects of the supplement
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, China Medical University, China
- Responsible party
- Principal investigator, Jung-Piao Tsao, China Medical University Hospital
- Investigators
- Jung-Piao Tsao, Study chair, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593535
- Sponsor's protocol ID
- CMUH111-REC3-081
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsao JP, Wu PY, Kuo HT, Hong WH, Chen CC, Wang MY, Korivi M, Cheng IS. Effect of astaxanthin supplementation on cycling performance, muscle damage biomarkers and oxidative stress in young adults: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Jul 4;17(1):180. doi: 10.1186/s13102-025-01221-3.
PubMed 40615903
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Astaxanthin Supplementation Enhances Cycling Performance and Attenuates Exhaustive Exercise-induced Muscle Damage and Oxidative Stress in Young Healthy Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06593535
- Acronym / sponsor ID
- CMUH111-REC3-081
- Conditions
- Healthy Volunteer
- Keywords
- Cycling performance, fatigue, ergogenic aids, lipid peroxidation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, China Medical University, China
- Study start
- 25 Jun 2022 (actual)
- Primary completion
- 17 Jul 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 19 Sep 2024 (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.
Ten young, healthy, physically active male college students were crossed over for AST or placebo supplements randomized into placebo or AST trials and orally consumed placebo or AST (28 mg/d) supplements for four days. Short-term AST supplementation enhanced endurance performance and effectively reversed cycling challenge-induced muscle damage and lipid peroxidation.
Detailed description
AST is composed of two β-ionone ring systems that are linked by a polyene chain and contain oxygenated keto and hydroxyl moieties, which are responsible for its powerful antioxidant activity. AST has been shown to have numerous health benefits in humans, including improved antioxidant and inflammatory status under different stress conditions. Therefore, this study will explore AST supplement to improve exercise-induced muscle damage and/or physiological anomalies in adults. Ten physically active male adults were randomized into placebo or AST trials and consumed placebo or AST (28 mg/d) supplements orally for 4 days. On day-4, participants performed an exhaustive cycling challenge at 75% V̇O2max, and the time to exhaustion (TTE) was recorded. Blood and gaseous samples were collected before, during, and immediately after cycling to determine changes in muscle damage, inflammation, oxidative stress, and substrate utilization.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Ten young healthy physically active male college students. Participants were crossed over for AST or placebo supplements, which was completed in four days. Between the crossover trials, participants had a one-week washout period to nullify the effects of the supplement
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: Placebo (Placebo trial), Other: Astaxanthin (AST trial)containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax. |
| Astaxanthin (AST) | Experimental | Other: Placebo (Placebo trial), Other: Astaxanthin (AST trial)Each capsule containing 4 mg of AST |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recruit people who are healthy are 20-40 years male and have exercise habits in college students
Key exclusion criteria (4 listed)
- Have smoking and drinking habits.
- Those who have implanted artificial joints in the past six months and have had recent surgery.
- People who feel unwell due to other reasons during the experiment.
- Take any drugs or Nutrition supplements in the past 3 months.
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 |
|---|---|---|
| Placebo (Placebo trial)The Placebo capsule supplement was taken for 4 days (7 capsules per day) | Other | Astaxanthin (AST), Placebo |
| Astaxanthin (AST trial)The AST capsule supplement was taken for 4 days, with a daily dosage of 28 mg of AST (equivalent to 7 capsules per day, each containing 4 mg of AST). | Other | Astaxanthin (AST), Placebo |
Primary outcome
Time to Exhaustion Exercise
Time frame: 21 days
Investigators conducted a double-blind test, where volunteers' basal maximal oxygen consumption (VO2max) was measured both before the intervention. The pretest VO2max is a reference to adjust the exercise intensity for each individual. To assess exhaustive endurance, participants exercised at 75% of their VO2max, and the cycling time from the start to the point of exhaustion was recorded.
Clinical Biochemistry of muscle damage biomarkers and blood glucose
Time frame: 21 days
Blood samples were collected at five different time points (one hour before (B), at the beginning (0 min), during (20 min, 40 min), and immediately (E) after the exhaustive cycling exercise challenge. Changes in blood glucose levels were estimated using blood from the fingertips via an Accu-Chek® Guide blood glucose glucometer (Roche, Mannheim, Germany). Muscle damage biomarkers, including creatine kinase (CK), lactate dehydrogenase (LDH), and uric acid (UA), were measured in the serum. The CK (EC2.7.3.2), LDH (EC 1.1.1.27), and UA (C97792) concentrations were estimated using commercial analytical reagents (Beckman Coulter). An automated clinical chemistry analyzer was used to measure CK and LDH levels on a Beckman Coulter AU5800 (Beckman Coulter Inc., CA, USA).
Clinical Biochemistry of total antioxidant capacity and lipid peroxidation
Time frame: 21 days
Blood samples were collected at five different time points (one hour before (B), at the beginning (0 min), during (20 min, 40 min), and immediately (E) after the exhaustive cycling exercise challenge. The scavenging ability of antioxidants (6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid, Trolox) was determined using a curve, and the amount of Trolox equivalent to the test serum's inhibition rate was calculated. Next, the level of malondialdehyde (MDA), a standard biomarker of lipid peroxidation, was determined by an ELISA kit provided by the Caman Company (Cayman Chemical Company, Michigan, USA). As described in the protocol, the reaction mixture was boiled at 90-100°C for 60 min, and the absorbance at 550 nm was measured using an ELISA plate reader (Tecan GENios, A-5082, Austria). The values are expressed as micromoles of MDA per liter.
Clinical Biochemistry of the inflammatory response
Time frame: 21 days
Blood samples were collected at five different time points (one hour before (B), at the beginning (0 min), during (20 min, 40 min), and immediately (E) after the exhaustive cycling exercise challenge. According to the manufacturer's instructions, the pro-inflammatory cytokine TNF-α was analyzed with a commercial ELISA kit (BioLegend, San Diego, CA). An enzyme immunoassay read The absorbance at 450 nm within 15 minutes (Tecan GENios, A-5082, Austria). Concentrations of C-reactive protein (CRP) were measured using a human ELISA kit (E-80CRP, Immunology Consultants Laboratory, Inc., Newberg, OR, USA). The sample absorbance was read at 450 nm within 30 min.
Assessment of the profile of mood state (POMS)
Time frame: 21 days
POMS brief was chosen for this study to evaluate the mood of individuals. After the TTE, participants completed the form, and their responses were analyzed using simple statistics. The results were shown in six dimensions, one positive: (1) vigor; and five negatives: (2) tension, (3) depression, (4) anger, (5) fatigue and (6) confusion.
Assessment of the RER, fat oxidation rate and carbohydrate oxidation rate
Time frame: 21 days
Ggaseous samples were collected at five different time points (one hour before (B), at the beginning (0 min), during (20 min, 40 min), and immediately (E) after the exhaustive cycling exercise challenge.The pulmonary oxygen consumption (VO2) and carbon dioxide production (VCO2) during exercise were used to determine metabolic substrate utilization. The gaseous exchange ratio during exercise reflects the relative contributions of carbohydrates and fat to energy metabolism. The RER was calculated by dividing the VCO2 value by the VO2 value (RER =(VCO2)⁄(VO2 )). The fat oxidation rate was calculated using the following equation: Fat oxidation rate=1.695×VO2-1.701×VCO2 ). Similarly, the carbohydrate oxidation rate was calculated using the following equation: Carbohydrate oxidation rate=4.585×VCO2-3.226×VO2
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 19 Sep 2024.
- Derived from this study: PubMed 40615903Tsao JP, Wu PY, Kuo HT, Hong WH, Chen CC, Wang MY, Korivi M, Cheng IS. Effect of astaxanthin supplementation on cycling performance, muscle damage biomarkers and oxidative stress in young adults: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2025 Jul 4;17(1):180. doi: 10.1186/s13102-025-01221-3.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Jung-Piao Tsao study chair
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Astaxanthin (AST trial) in people with Healthy Volunteer, run by China Medical University Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 19 Sep 2024. 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 Taiwan. 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?
Time to Exhaustion Exercise (time frame: 21 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06593535, which also lists 1 linked publication.
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 19 Sep 2024.