NCT06593535

Brief 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. Short-term AST supplementation enhanced endurance performance and effectively reversed cycling challenge-induced muscle damage and lipid peroxidation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2022

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2022

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

22 days

First QC Date

September 5, 2024

Last Update Submit

September 15, 2024

Conditions

Keywords

Cycling performancefatigueergogenic aidslipid peroxidation

Outcome Measures

Primary Outcomes (6)

  • 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.

    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).

    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.

    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.

    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.

    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

    21 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

containing edible yellow No. 4, edible yellow No. 5, sucrose, silica, talc, oxidized starch, gelatin, magnesium stearate, and palm wax.

Other: Placebo (Placebo trial)Other: Astaxanthin (AST trial)

Astaxanthin (AST)

EXPERIMENTAL

Each capsule containing 4 mg of AST

Other: Placebo (Placebo trial)Other: Astaxanthin (AST trial)

Interventions

The Placebo capsule supplement was taken for 4 days (7 capsules per day)

Astaxanthin (AST)Placebo

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).

Astaxanthin (AST)Placebo

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recruit people who are healthy are 20-40 years male and have exercise habits in college students

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University

Taichung, 404332, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Fatigue

Interventions

astaxanthine

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jung-Piao Tsao

    China Medical University, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 19, 2024

Study Start

June 25, 2022

Primary Completion

July 17, 2022

Study Completion

September 20, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations