Inflammatory ResponseNCT05409092
Astaxanthin, Exercise Inflammation, Skin Health
A study testing Astaxanthin in people with Inflammatory Response and Metabolic Disturbance, run by Appalachian State University at 1 site in United States.
Trial summary
Vigorous exercise can stress the body. Consuming special types of diet supplements may help the body recover better from exercise. This includes a bright red supplement called astaxanthin that is found in certain algae and causes the pink-red color in salmon. Read more about this study
- Who is it for?
- Ages 18 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Response, Metabolic Disturbance, Immune Suppression
- What is being tested?
- Astaxanthin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2022to 30 Dec 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 18 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, ages 18-57 years.
- Non-smoker.
- Capable of running 2.25 h on laboratory treadmills at 70% VO2max (close to marathon race pace).
- Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation and immune function (especially Advil, Motrin, aspirin, and similar anti-inflammatory drugs) for the duration of the 10-week study. (Review supplement and medication use with the Research Manager during orientation).
- Agree to taper exercise training prior to each of the two lab running sessions (as if preparing for a race).
- Willing to avoid astaxanthin supplements (other than what is provided) and natural sources of astaxanthin including algae, yeast, salmon, trout, krill, shrimp and crayfish during the 10-week study.
- Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
- Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.
Who cannot join
- Inability to comply with study requirements.
- Body weight below 110 pounds.
- Pregnant or breastfeeding.
- Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
- Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
- History of allergic reactions to astaxanthin.
- Using drugs with 5-alpha-reductase inhibitor (Proscar, Propecia, Avodart, Jalyn).
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Influence of Astaxanthin Supplementation on Exercise-Induced Inflammation and Skin Health
Vigorous exercise can stress the body. Consuming special types of diet supplements may help the body recover better from exercise. This includes a bright red supplement called astaxanthin that is found in certain algae and causes the pink-red color in salmon. Astaxanthin is an antioxidant and may protect cells from damage and improve the way the immune system functions. The main purpose of this study is to determine if 4 weeks of consuming astaxanthin improves recovery from 2.25 hours of intensive running on a treadmill. This study will also measure whether or not astaxanthin supplementation improves skin health
Read the detailed description
RESEARCH PROCEDURES The research procedures will be conducted at the Human Performance Laboratory (Room 1201, Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come to the Human Performance Lab (HPL) for orientation/baseline testing with pre-supplementation blood sample collections, two 2.25 h running sessions, and additional lab visits to provide 1-day 7:00 am recovery blood samples) (thus 6 total performance lab visits). Skin health measurements will occur the morning before and during Performance Lab Visits #1, 2, 4, 5 (thus 8 total visits, with four of them occurring with HPL visits and four of them occurring separately). The total amount of time subjects will be asked to volunteer for this study is about 16 hours at the North Carolina Research Campus (over a 10-week period).
Orientation/Baseline Testing (Performance Lab Visit #1) Four weeks prior to the first 2.25 h running session, subjects will report to the Human Performance Laboratory at approximately 7:00-8:30 am. Skin health measurements will be conducted the day before (following review of the consent form, with signing) and the day of baseline testing. Following the second skin health measurement, demographic and training histories will be acquired with questionnaires. A symptom inventory will be conducted using a 4-week retrospective questionnaire. Delayed onset of muscle soreness (DOMS) and the Profile of Mood States (POMS) will be assessed with standardized questionnaires. A blood sample will be collected in an overnight fasted state to coincide with the same time of the day for the post-supplementation blood draw. Body composition will be measured with the seca BIA and Bod Pod body composition analyzer (Life Measurement, Concord, CA). Study participants will be tested for maximal aerobic capacity (VO2max) during a graded, treadmill test with the Cosmed CPET metabolic device (Cosmed, Rome, Italy). Supplements for the 4-week supplementation period will be supplied in food supplement trays to facilitate compliance to the supplementation protocol. 3-day food records and the food list will be supplied with thorough instructions (for the 3-day period prior to the 2.25 hour treadmill running sessions).
4-Week Supplementation Periods Study participants will be randomized to astaxanthin and placebo groups, with supplements ingested daily (with the first meal) for 4-weeks prior to participation in the first 2.25 h running session. To assess potential adverse effects, a symptom inventory will be conducted using a 4-week retrospective questionnaire before and after the 4-week supplementation period. After a 2-week washout period, participants will repeat all procedures using the counterbalanced supplement. The astaxanthin and placebo supplements will look identical and be supplied by the sponsor. The astaxanthin capsule will contain 8 mg of astaxanthin from freshwater algae in starch beadlets, and the placebo capsules will contain just the starch beadlets with natural red coloring from the pitaya fruit. Four ounces of sockeye salmon contains about 4.5 milligrams of astaxanthin, with much higher levels in arctic shrimp and krill. Natural astaxanthin is sold around the world as a natural antioxidant supplement with a recommended dosage of 4 mg to 12 mg a day. LycoRed sources astaxanthin from Haematococcus pluvialis, a freshwater algae species of Chlorophyta from the family Haematococcaceae. This species is well known for its high content of the strong antioxidant astaxanthin, which is important in aquaculture, and cosmetics.
2.25 h Running Session (Performance Lab Visit #2, Skin Health Tests #3, #4) During the 3-day period prior to the 2.25 h running session, subjects will taper exercise training and ingest a moderate-carbohydrate diet using a food list restricting high fat foods, visible fats, and polyphenols. Subjects will record all food and beverage intake during the 3-day period, with macro- and micro-nutrient intake assessed using the Food Processor dietary analysis software system (ESHA Research, Salem, OR).
Skin health measurements will be conducted the day before and the day of the running session (#3, #4) (overnight fasted state). Study participants will report to the Human Performance Lab in an overnight fasted state, take the skin health tests, provide a blood sample, ingest astaxanthin or the placebo supplement with water, then run 2.25 h at high intensity (70% VO2max) while ingesting water alone (3 ml/kg every 15 minutes). Blood samples will be collected at 0 h, 1.5 h, 3 h, and 21 h post-exercise.
2-WEEKS WASHOUT, CROSSOVER, REPEAT Subjects will engage in a 2-week washout period without supplements, crossover, and then repeat all procedures (Skin tests #4 through #8; Performance Lab visits #4,5,6). NOTE: Subjects randomized during the first trial to astaxanthin will have 6 weeks of washout when counting the 4-week placebo period.
- Being tested
- Astaxanthin, Placebo
- Keywords
- astaxanthin, exercise, immune function, proteomics, cytokines, muscle damage
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AstaxanthinDietary supplement
8 mg/day in one capsule for 4 weeks
PlaceboDietary supplement
8 mg/day in one capsule for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Astaxanthin | Experimental | The astaxanthin capsules will contain 8 mg of astaxanthin from freshwater algae in starch beadlets. Ingested daily for 4 weeks. Receives: Dietary Supplement: Astaxanthin |
| Placebo | Placebo comparator | The placebo capsules will contain just the starch beadlets with natural red coloring from the pitaya fruit. Ingested daily for 4 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lipid mediators
Plasma concentrations of arachadonic acid oxidized derivatives from LC-MS-MS analysis
Measured: Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion
Secondary outcomes (2)
Plasma proteins
Plasma concentrations of immune- and inflammation-related proteins from proteomics profiling using LC-MS-MS analysis
Measured: Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion
Plasma cytokine panel
Plasma concentrations of cytokines most influenced by exercise inclduing IL6, IL8, IL10, MCP-1, IL1ra, GCSF
Measured: Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start19 Jan 2022
- Primary completion30 Jul 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized treatment, double blinded procedures, crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- LycoRed Ltd.
- Responsible party
- Sponsor
- Investigators
- David C Nieman, DrPH, Principal investigator, Appalachian State Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409092
- Sponsor's protocol ID
- 22-0100
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2022
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share data upon request.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Astaxanthin Supplementation on Exercise-Induced Inflammation and Skin Health
- ClinicalTrials.gov ID
- NCT05409092
- Acronym / sponsor ID
- 22-0100
- Keywords
- astaxanthin, exercise, immune function, proteomics, cytokines, muscle damage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- LycoRed Ltd.
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 8 Jun 2022 (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.
Vigorous exercise can stress the body. Consuming special types of diet supplements may help the body recover better from exercise. This includes a bright red supplement called astaxanthin that is found in certain algae and causes the pink-red color in salmon. Astaxanthin is an antioxidant and may protect cells from damage and improve the way the immune system functions. The main purpose of this study is to determine if 4 weeks of consuming astaxanthin improves recovery from 2.25 hours of intensive running on a treadmill. This study will also measure whether or not astaxanthin supplementation improves skin health
Detailed description
RESEARCH PROCEDURES The research procedures will be conducted at the Human Performance Laboratory (Room 1201, Plants for Human Health Institute Building, 600 Laureate Way), operated by Appalachian State University at the North Carolina Research Campus (NCRC) in Kannapolis, NC. Subjects will come to the Human Performance Lab (HPL) for orientation/baseline testing with pre-supplementation blood sample collections, two 2.25 h running sessions, and additional lab visits to provide 1-day 7:00 am recovery blood samples) (thus 6 total performance lab visits). Skin health measurements will occur the morning before and during Performance Lab Visits #1, 2, 4, 5 (thus 8 total visits, with four of them occurring with HPL visits and four of them occurring separately). The total amount of time subjects will be asked to volunteer for this study is about 16 hours at the North Carolina Research Campus (over a 10-week period).
Orientation/Baseline Testing (Performance Lab Visit #1) Four weeks prior to the first 2.25 h running session, subjects will report to the Human Performance Laboratory at approximately 7:00-8:30 am. Skin health measurements will be conducted the day before (following review of the consent form, with signing) and the day of baseline testing. Following the second skin health measurement, demographic and training histories will be acquired with questionnaires. A symptom inventory will be conducted using a 4-week retrospective questionnaire. Delayed onset of muscle soreness (DOMS) and the Profile of Mood States (POMS) will be assessed with standardized questionnaires. A blood sample will be collected in an overnight fasted state to coincide with the same time of the day for the post-supplementation blood draw. Body composition will be measured with the seca BIA and Bod Pod body composition analyzer (Life Measurement, Concord, CA). Study participants will be tested for maximal aerobic capacity (VO2max) during a graded, treadmill test with the Cosmed CPET metabolic device (Cosmed, Rome, Italy). Supplements for the 4-week supplementation period will be supplied in food supplement trays to facilitate compliance to the supplementation protocol. 3-day food records and the food list will be supplied with thorough instructions (for the 3-day period prior to the 2.25 hour treadmill running sessions).
4-Week Supplementation Periods Study participants will be randomized to astaxanthin and placebo groups, with supplements ingested daily (with the first meal) for 4-weeks prior to participation in the first 2.25 h running session. To assess potential adverse effects, a symptom inventory will be conducted using a 4-week retrospective questionnaire before and after the 4-week supplementation period. After a 2-week washout period, participants will repeat all procedures using the counterbalanced supplement. The astaxanthin and placebo supplements will look identical and be supplied by the sponsor. The astaxanthin capsule will contain 8 mg of astaxanthin from freshwater algae in starch beadlets, and the placebo capsules will contain just the starch beadlets with natural red coloring from the pitaya fruit. Four ounces of sockeye salmon contains about 4.5 milligrams of astaxanthin, with much higher levels in arctic shrimp and krill. Natural astaxanthin is sold around the world as a natural antioxidant supplement with a recommended dosage of 4 mg to 12 mg a day. LycoRed sources astaxanthin from Haematococcus pluvialis, a freshwater algae species of Chlorophyta from the family Haematococcaceae. This species is well known for its high content of the strong antioxidant astaxanthin, which is important in aquaculture, and cosmetics.
2.25 h Running Session (Performance Lab Visit #2, Skin Health Tests #3, #4) During the 3-day period prior to the 2.25 h running session, subjects will taper exercise training and ingest a moderate-carbohydrate diet using a food list restricting high fat foods, visible fats, and polyphenols. Subjects will record all food and beverage intake during the 3-day period, with macro- and micro-nutrient intake assessed using the Food Processor dietary analysis software system (ESHA Research, Salem, OR).
Skin health measurements will be conducted the day before and the day of the running session (#3, #4) (overnight fasted state). Study participants will report to the Human Performance Lab in an overnight fasted state, take the skin health tests, provide a blood sample, ingest astaxanthin or the placebo supplement with water, then run 2.25 h at high intensity (70% VO2max) while ingesting water alone (3 ml/kg every 15 minutes). Blood samples will be collected at 0 h, 1.5 h, 3 h, and 21 h post-exercise.
2-WEEKS WASHOUT, CROSSOVER, REPEAT Subjects will engage in a 2-week washout period without supplements, crossover, and then repeat all procedures (Skin tests #4 through #8; Performance Lab visits #4,5,6). NOTE: Subjects randomized during the first trial to astaxanthin will have 6 weeks of washout when counting the 4-week placebo period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized treatment, double blinded procedures, crossover
| Arm | Type | Receives |
|---|---|---|
| Astaxanthin | Experimental | Dietary Supplement: AstaxanthinThe astaxanthin capsules will contain 8 mg of astaxanthin from freshwater algae in starch beadlets. Ingested daily for 4 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo capsules will contain just the starch beadlets with natural red coloring from the pitaya fruit. Ingested daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female, ages 18-57 years.
- Non-smoker.
- Capable of running 2.25 h on laboratory treadmills at 70% VO2max (close to marathon race pace).
- Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation and immune function (especially Advil, Motrin, aspirin, and similar anti-inflammatory drugs) for the duration of the 10-week study. (Review supplement and medication use with the Research Manager during orientation).
- Agree to taper exercise training prior to each of the two lab running sessions (as if preparing for a race).
Key exclusion criteria (7 listed)
- Inability to comply with study requirements.
- Body weight below 110 pounds.
- Pregnant or breastfeeding.
- Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
- Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
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 |
|---|---|---|
| Astaxanthin8 mg/day in one capsule for 4 weeks | Dietary supplement | Astaxanthin |
| Placebo8 mg/day in one capsule for 4 weeks | Dietary supplement | Placebo |
Primary outcome
Plasma lipid mediators
Time frame: Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion
Plasma concentrations of arachadonic acid oxidized derivatives from LC-MS-MS analysis
2 secondary outcomes
Plasma proteins
Time frame: Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion
Plasma cytokine panel
Time frame: Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion
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 9 Jun 2023.
- Individual participant dataSharing planned: Yes. Will share data upon request.
Related trials for Inflammatory Response
Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Crohn Disease
Not yet recruitingObservational study
Comparative Study of the Genomic Characteristics of Uropathogenic Escherichia Coli According to the Severity of Community-Acquired Urinary Tract Infections in Guadeloupe (COLIGENURI)
Urinary Tract Infections
Not yet recruitingPhase 4
Efficacy of Upadacitinib Re-induction Therapy in Patients With Ulcerative Colitis Who Lost Response to 30 mg Maintenance Dose
Ulcerative Colitis (UC)
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
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.
David C Nieman, DrPH principal investigator
Appalachian State Univ
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 in people with Inflammatory Response and Metabolic Disturbance, run by Appalachian State University 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 8 inclusion and 7 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 9 Jun 2023. 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?
Plasma lipid mediators (time frame: Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exerciseingestion to 8- and 24-hours post-ingestion). 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 9 Jun 2023.