- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06593535
Evaluation of Astaxanthin Properties on Anti-fatigue
September 15, 2024 updated by: Jung-Piao Tsao, China Medical University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taichung, Taiwan, 404332
- China Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Recruit people who are healthy are 20-40 years male and have exercise habits in college students
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax.
|
The Placebo capsule supplement was taken for 4 days (7 capsules per day)
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).
|
|
Experimental: Astaxanthin (AST)
Each capsule containing 4 mg of AST
|
The Placebo capsule supplement was taken for 4 days (7 capsules per day)
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
21 days
|
|
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).
|
21 days
|
|
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.
|
21 days
|
|
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.
|
21 days
|
|
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.
|
21 days
|
|
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
|
21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Jung-Piao Tsao, China Medical University, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 25, 2022
Primary Completion (Actual)
July 17, 2022
Study Completion (Actual)
September 20, 2022
Study Registration Dates
First Submitted
September 5, 2024
First Submitted That Met QC Criteria
September 10, 2024
First Posted (Estimated)
September 12, 2024
Study Record Updates
Last Update Posted (Estimated)
September 19, 2024
Last Update Submitted That Met QC Criteria
September 15, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- CMUH111-REC3-081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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