Astaxanthin, Exercise Inflammation, Skin Health

June 8, 2023 updated by: Appalachian State University

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Kannapolis, North Carolina, United States, 28081
        • Appalachian State University Human Performance Lab, North Carolina Research Campus

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 57 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Astaxanthin
The astaxanthin capsules will contain 8 mg of astaxanthin from freshwater algae in starch beadlets. Ingested daily for 4 weeks.
Dietary supplement: Astaxanthin
8 mg/day in one capsule for 4 weeks
Placebo Comparator: Placebo
The placebo capsules will contain just the starch beadlets with natural red coloring from the pitaya fruit. Ingested daily for 4 weeks.
Dietary supplement: Placebo
8 mg/day in one capsule for 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 concentrations of immune- and inflammation-related proteins from proteomics profiling using LC-MS-MS analysis
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
Plasma concentrations of cytokines most influenced by exercise inclduing IL6, IL8, IL10, MCP-1, IL1ra, GCSF
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Appalachian State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
LycoRed Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David C Nieman, DrPH, Appalachian State Univ

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-0100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will share data upon request.

IPD Sharing Time Frame

September 2022; indefinitely

IPD Sharing Access Criteria

Upon request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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