Healthy AgingNCT07876193
Effects of Astaxanthin Supplementation on Metabolism, Cognition, and Physical Function in Older Adults
A study testing Astaxanthin Oral Capsule in people with Healthy Aging, run by University of North Alabama at 1 site in United States.
Trial summary
This study evaluated whether astaxanthin supplementation affects the body's ability to use fat for energy, cognitive performance, and physical function in healthy older adults. In this randomized, double-blind, placebo-controlled crossover trial, participants received both astaxanthin and a placebo during separate… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Astaxanthin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2025to 1 Jun 2025
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 60 years or older.
- Community-dwelling individuals.
- Able to provide written informed consent.
- No physician-identified mobility impairment, cardiovascular disease, or cognitive dysfunction.
- Refrained from antioxidant supplementation for at least two weeks before enrollment.
Who cannot join
- Younger than 60 years.
- Physician-identified mobility impairment, cardiovascular disease, or cognitive dysfunction.
- Timed Up and Go performance exceeding age-specific screening thresholds for impaired mobility.
- Antioxidant supplement use within two weeks before enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Alabama
Florence, Alabama, 35661
About this study
Official title: Effects of Astaxanthin on Fat Oxidation, Cognitive Performance, and Physical Functionality in Older Adults
This study evaluated whether astaxanthin supplementation affects the body's ability to use fat for energy, cognitive performance, and physical function in healthy older adults. In this randomized, double-blind, placebo-controlled crossover trial, participants received both astaxanthin and a placebo during separate study periods. Neither the participants nor the researchers conducting the assessments knew which treatment participants were receiving during each period. Assessments were used to compare outcomes between the astaxanthin and placebo conditions.
Read the detailed description
This single-center study evaluated the effects of astaxanthin supplementation on exercise substrate utilization, walking economy, cognitive performance, physical function, and cardiometabolic markers in community-dwelling older adults. The study examined supplementation without an accompanying structured exercise training intervention.
The study used a randomized, double-blind, placebo-controlled, counterbalanced crossover design. Participants received astaxanthin and placebo during two five-week supplementation periods separated by a one-week washout. An independent investigator generated the treatment sequence and coded the supplement bottles to maintain blinding. Astaxanthin capsules provided 12 milligrams of astaxanthin in olive oil, while matched placebo capsules contained olive oil alone. Participants were instructed to take one capsule daily with a meal containing dietary fat. Adherence was assessed by counting capsules returned at the end of each supplementation period.
Participants attended four laboratory visits: a familiarization visit, a baseline assessment before supplementation, and an assessment following each supplementation period. Familiarization included demonstrations and practice of the cognitive and physical performance tasks to reduce learning effects during subsequent assessments.
Testing visits were conducted at approximately the same time of day for each participant. Participants arrived after an overnight fast of at least eight hours and were instructed to avoid alcohol, caffeine, and strenuous exercise for 24 hours before testing. A 24-hour dietary recall was collected during familiarization, and participants were asked to replicate that intake on the day before subsequent testing visits.
Metabolic assessments used indirect calorimetry during a progressive submaximal treadmill walking protocol. Participants completed four stages lasting four minutes each, at speeds of 3.2, 4.0, 4.8, and 5.6 kilometers per hour, with the treadmill incline maintained at 1 percent. Oxygen consumption and carbon dioxide production were measured to characterize substrate utilization using the respiratory exchange ratio. Walking economy was calculated as oxygen consumption per unit distance. Heart rate and perceived exertion were recorded at the end of each stage. Participants wore a safety harness for fall prevention without body-weight support.
Following approximately ten minutes of passive recovery, participants completed computerized cognitive assessments and physical function testing. A three-minute incongruent Flanker task assessed inhibitory control, and a five-minute task-switching test assessed cognitive flexibility. Cognitive performance was characterized using reaction time, response speed, and correct responses per second.
Physical function was assessed using the Timed Up and Go test and handgrip dynamometry. The Timed Up and Go test measured the time required to stand from a chair, walk three meters, turn, return, and sit down. Handgrip testing included three maximal efforts per hand, alternating sides with recovery between attempts. The highest recorded value was used to characterize maximal grip strength.
Fasting capillary blood samples were collected by finger prick for lipid panel assessment using a point-of-care analyzer. Measurements included total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and derived lipid indices.
Within-participant comparisons between astaxanthin and placebo were used to evaluate supplementation effects. Analyses of treadmill outcomes also considered walking speed and interactions between supplementation condition and walking speed.
- Conditions
- Healthy Aging
- Being tested
- Astaxanthin Oral Capsule, Olive Oil Placebo
- Keywords
- Astaxanthin, Older Adults, Dietary Supplementation, Fat Oxidation, Substrate Utilization, Walking Economy, Cognitive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Astaxanthin Oral CapsuleDietary supplement
Also called Astaxanthin
Astaxanthin was administered orally at a dose of 12 mg per day as one capsule containing astaxanthin in olive oil. Participants took one capsule daily with a meal containing dietary fat for five weeks. Capsules were supplied by AstaReal, Inc.
Olive Oil PlaceboDietary supplement
The placebo was administered orally as one matched capsule containing olive oil without astaxanthin. Participants took one capsule daily with a meal containing dietary fat for five weeks. Placebo capsules were supplied by AstaReal, Inc.
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin | Experimental | Participants received one capsule containing 12 mg of astaxanthin in olive oil daily for five weeks Receives: Dietary Supplement: Astaxanthin Oral Capsule |
| Placebo | Placebo comparator | Participants received one matched placebo capsule containing olive oil only daily for five weeks Receives: Dietary Supplement: Olive Oil Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Exchange Ratio During Submaximal Walking
Respiratory exchange ratio, calculated as carbon dioxide production divided by oxygen consumption, measured by indirect calorimetry during treadmill walking at 3.2, 4.0, 4.8, and 5.6 kilometers per hour at a 1 percent incline. Values were averaged over the final minute of each stage.
Measured: Baseline and At the end of each five-week supplementation period.
Incongruent Flanker Task Reaction Time
Reaction time, expressed in milliseconds, during a three-minute computerized incongruent Flanker task. Participants identified the direction of a central arrow while ignoring surrounding arrows. Shorter reaction times indicate faster responses.
Measured: Baseline and At the end of each five-week supplementation period.
Timed Up and Go Completion Time
Time, expressed in seconds, required to rise from a chair, walk three meters, turn, return to the chair, and sit down during the Timed Up and Go test. One timed trial was performed at each assessment. Shorter completion times indicate better functional mobility.
Measured: Baseline and At the end of each five-week supplementation period.
Incongruent Flanker Task Response Speed
Response speed, calculated as the reciprocal of reaction time, during a three-minute computerized incongruent Flanker task. Participants identified the direction of a central arrow while ignoring surrounding arrows. Higher values indicate faster responses.
Measured: Baseline and At the end of each five-week supplementation period.
Incongruent Flanker Task Correct Response Rate
Rate of correct responses, expressed as correct responses per second, during a three-minute computerized incongruent Flanker task. Participants identified the direction of a central arrow while ignoring surrounding arrows. Higher values indicate a greater rate of correct responses.
Measured: Baseline and At the end of each five-week supplementation period.
Secondary outcomes (9)
Task-Switching Reaction Time
Reaction time, expressed in milliseconds, during a five-minute computerized task-switching test. Participants selected responses according to the color and numerical characteristics of displayed numbers. Shorter reaction times indicate faster responses.
Measured: Baseline and At the end of each five-week supplementation period.
Maximal Handgrip Strength
Maximal handgrip strength, expressed in kilograms, measured using a hydraulic hand dynamometer. Participants performed three maximal efforts per hand, alternating sides with at least 30 seconds of recovery between attempts. The highest value recorded from either hand was used for analysis. Higher values indicate greater grip strength.
Measured: Baseline and At the end of each five-week supplementation period.
Oxygen Cost of Walking
Oxygen cost per unit distance, expressed in milliliters of oxygen per kilogram of body mass per meter walked, assessed by indirect calorimetry during treadmill walking at 3.2, 4.0, 4.8, and 5.6 kilometers per hour at a 1 percent incline. Lower values indicate better walking economy.
Measured: Baseline and At the end of each five-week supplementation period.
Fasting Total Cholesterol Concentration
Total cholesterol concentration in fasting capillary blood collected by finger prick and analyzed using a Cholestech LDX analyzer. Results are expressed in milligrams per deciliter.
Measured: Baseline and At the end of each five-week supplementation period.
Fasting High-Density Lipoprotein Cholesterol Concentration
High-density lipoprotein cholesterol concentration in fasting capillary blood assessed using a Cholestech LDX analyzer. Results are expressed in milligrams per deciliter.
Measured: Baseline and At the end of each five-week supplementation period.
Fasting Low-Density Lipoprotein Cholesterol Concentration
Low-density lipoprotein cholesterol concentration obtained from fasting capillary blood lipid panel analysis using a Cholestech LDX analyzer. Results are expressed in milligrams per deciliter.
Measured: Baseline and At the end of each five-week supplementation period.
Fasting Triglyceride Concentration
Triglyceride concentration in fasting capillary blood assessed using a Cholestech LDX analyzer. Results are expressed in milligrams per deciliter.
Measured: Baseline and At the end of each five-week supplementation period.
Task-Switching Response Speed
Response speed, calculated as the reciprocal of reaction time, during a five-minute computerized task-switching test. Participants selected responses according to the color and numerical characteristics of displayed numbers. Higher values indicate faster responses.
Measured: Baseline and At the end of each five-week supplementation period.
Task-Switching Correct Response Rate
Rate of correct responses, expressed as correct responses per second, during a five-minute computerized task-switching test. Participants selected responses according to the color and numerical characteristics of displayed numbers. Higher values indicate a greater rate of correct responses.
Measured: Baseline and At the end of each five-week supplementation period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start5 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants were randomly assigned to one of two treatment sequences: astaxanthin followed by placebo or placebo followed by astaxanthin. Each supplementation period lasted five weeks, with a one-week washout between periods. All participants received both interventions and served as their own controls.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Alabama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joice Lacruz, University of North Alabama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876193
- Sponsor's protocol ID
- 2024-71
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Findings will be disseminated through scientific publications and presentations using aggregate results.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Astaxanthin on Fat Oxidation, Cognitive Performance, and Physical Functionality in Older Adults
- ClinicalTrials.gov ID
- NCT07876193
- Acronym / sponsor ID
- 2024-71
- Conditions
- Healthy Aging
- Keywords
- Astaxanthin, Older Adults, Dietary Supplementation, Fat Oxidation, Substrate Utilization, Walking Economy, Cognitive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of North AlabamaUniversity, hospital or other
- Study start
- 5 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 15 Oct 2026 (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.
This study evaluated whether astaxanthin supplementation affects the body's ability to use fat for energy, cognitive performance, and physical function in healthy older adults. In this randomized, double-blind, placebo-controlled crossover trial, participants received both astaxanthin and a placebo during separate study periods. Neither the participants nor the researchers conducting the assessments knew which treatment participants were receiving during each period. Assessments were used to compare outcomes between the astaxanthin and placebo conditions.
Detailed description
This single-center study evaluated the effects of astaxanthin supplementation on exercise substrate utilization, walking economy, cognitive performance, physical function, and cardiometabolic markers in community-dwelling older adults. The study examined supplementation without an accompanying structured exercise training intervention.
The study used a randomized, double-blind, placebo-controlled, counterbalanced crossover design. Participants received astaxanthin and placebo during two five-week supplementation periods separated by a one-week washout. An independent investigator generated the treatment sequence and coded the supplement bottles to maintain blinding. Astaxanthin capsules provided 12 milligrams of astaxanthin in olive oil, while matched placebo capsules contained olive oil alone. Participants were instructed to take one capsule daily with a meal containing dietary fat. Adherence was assessed by counting capsules returned at the end of each supplementation period.
Participants attended four laboratory visits: a familiarization visit, a baseline assessment before supplementation, and an assessment following each supplementation period. Familiarization included demonstrations and practice of the cognitive and physical performance tasks to reduce learning effects during subsequent assessments.
Testing visits were conducted at approximately the same time of day for each participant. Participants arrived after an overnight fast of at least eight hours and were instructed to avoid alcohol, caffeine, and strenuous exercise for 24 hours before testing. A 24-hour dietary recall was collected during familiarization, and participants were asked to replicate that intake on the day before subsequent testing visits.
Metabolic assessments used indirect calorimetry during a progressive submaximal treadmill walking protocol. Participants completed four stages lasting four minutes each, at speeds of 3.2, 4.0, 4.8, and 5.6 kilometers per hour, with the treadmill incline maintained at 1 percent. Oxygen consumption and carbon dioxide production were measured to characterize substrate utilization using the respiratory exchange ratio. Walking economy was calculated as oxygen consumption per unit distance. Heart rate and perceived exertion were recorded at the end of each stage. Participants wore a safety harness for fall prevention without body-weight support.
Following approximately ten minutes of passive recovery, participants completed computerized cognitive assessments and physical function testing. A three-minute incongruent Flanker task assessed inhibitory control, and a five-minute task-switching test assessed cognitive flexibility. Cognitive performance was characterized using reaction time, response speed, and correct responses per second.
Physical function was assessed using the Timed Up and Go test and handgrip dynamometry. The Timed Up and Go test measured the time required to stand from a chair, walk three meters, turn, return, and sit down. Handgrip testing included three maximal efforts per hand, alternating sides with recovery between attempts. The highest recorded value was used to characterize maximal grip strength.
Fasting capillary blood samples were collected by finger prick for lipid panel assessment using a point-of-care analyzer. Measurements included total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, triglycerides, and derived lipid indices.
Within-participant comparisons between astaxanthin and placebo were used to evaluate supplementation effects. Analyses of treadmill outcomes also considered walking speed and interactions between supplementation condition and walking speed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two treatment sequences: astaxanthin followed by placebo or placebo followed by astaxanthin. Each supplementation period lasted five weeks, with a one-week washout between periods. All participants received both interventions and served as their own controls.
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Experimental | Dietary Supplement: Astaxanthin Oral CapsuleParticipants received one capsule containing 12 mg of astaxanthin in olive oil daily for five weeks |
| Placebo | Placebo comparator | Dietary Supplement: Olive Oil PlaceboParticipants received one matched placebo capsule containing olive oil only daily for five weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 60 years or older.
- Community-dwelling individuals.
- Able to provide written informed consent.
- No physician-identified mobility impairment, cardiovascular disease, or cognitive dysfunction.
- Refrained from antioxidant supplementation for at least two weeks before enrollment.
Key exclusion criteria (4 listed)
- Younger than 60 years.
- Physician-identified mobility impairment, cardiovascular disease, or cognitive dysfunction.
- Timed Up and Go performance exceeding age-specific screening thresholds for impaired mobility.
- Antioxidant supplement use within two weeks before enrollment.
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 |
|---|---|---|
| Astaxanthin Oral CapsuleAlso: AstaxanthinAstaxanthin was administered orally at a dose of 12 mg per day as one capsule containing astaxanthin in olive oil. Participants took one capsule daily with a meal containing dietary fat for five weeks. Capsules were supplied by AstaReal, Inc. | Dietary supplement | Astaxanthin |
| Olive Oil PlaceboThe placebo was administered orally as one matched capsule containing olive oil without astaxanthin. Participants took one capsule daily with a meal containing dietary fat for five weeks. Placebo capsules were supplied by AstaReal, Inc. | Dietary supplement | Placebo |
Primary outcome
Respiratory Exchange Ratio During Submaximal Walking
Time frame: Baseline and At the end of each five-week supplementation period.
Respiratory exchange ratio, calculated as carbon dioxide production divided by oxygen consumption, measured by indirect calorimetry during treadmill walking at 3.2, 4.0, 4.8, and 5.6 kilometers per hour at a 1 percent incline. Values were averaged over the final minute of each stage.
Incongruent Flanker Task Reaction Time
Time frame: Baseline and At the end of each five-week supplementation period.
Reaction time, expressed in milliseconds, during a three-minute computerized incongruent Flanker task. Participants identified the direction of a central arrow while ignoring surrounding arrows. Shorter reaction times indicate faster responses.
Timed Up and Go Completion Time
Time frame: Baseline and At the end of each five-week supplementation period.
Time, expressed in seconds, required to rise from a chair, walk three meters, turn, return to the chair, and sit down during the Timed Up and Go test. One timed trial was performed at each assessment. Shorter completion times indicate better functional mobility.
Incongruent Flanker Task Response Speed
Time frame: Baseline and At the end of each five-week supplementation period.
Response speed, calculated as the reciprocal of reaction time, during a three-minute computerized incongruent Flanker task. Participants identified the direction of a central arrow while ignoring surrounding arrows. Higher values indicate faster responses.
Incongruent Flanker Task Correct Response Rate
Time frame: Baseline and At the end of each five-week supplementation period.
Rate of correct responses, expressed as correct responses per second, during a three-minute computerized incongruent Flanker task. Participants identified the direction of a central arrow while ignoring surrounding arrows. Higher values indicate a greater rate of correct responses.
9 secondary outcomes
Task-Switching Reaction Time
Time frame: Baseline and At the end of each five-week supplementation period.
Maximal Handgrip Strength
Time frame: Baseline and At the end of each five-week supplementation period.
Oxygen Cost of Walking
Time frame: Baseline and At the end of each five-week supplementation period.
Fasting Total Cholesterol Concentration
Time frame: Baseline and At the end of each five-week supplementation period.
Fasting High-Density Lipoprotein Cholesterol Concentration
Time frame: Baseline and At the end of each five-week supplementation period.
Fasting Low-Density Lipoprotein Cholesterol Concentration
Time frame: Baseline and At the end of each five-week supplementation period.
Fasting Triglyceride Concentration
Time frame: Baseline and At the end of each five-week supplementation period.
Task-Switching Response Speed
Time frame: Baseline and At the end of each five-week supplementation period.
Task-Switching Correct Response Rate
Time frame: Baseline and At the end of each five-week supplementation period.
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 20 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Findings will be disseminated through scientific publications and presentations using aggregate results.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Oral Capsule in people with Healthy Aging, run by University of North Alabama at 1 site in United States.
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 5 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 20 Oct 2026. 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 United States. 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?
Respiratory Exchange Ratio During Submaximal Walking (time frame: Baseline and At the end of each five-week supplementation period.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Oct 2026.