Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2025-12-24 @ 3:55 PM
NCT ID:
NCT05409092
Eligibility Criteria:
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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
57 Years
Study:
NCT05409092
Study Brief:
Protocol Section:
NCT05409092