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:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT05409105
Eligibility Criteria:
Inclusion Criteria:
* Male or female cyclist, ages 18-60 years, and capable of cycling 2.25 h in the lab on trainers at 70% VO2max (close to race pace).
* Non-smoker, and generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis. Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
* Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation (especially NSAIDs) for the duration of the 6-week study and at least a 2-week period prior to the study.
* Agree to taper their exercise routine prior to each of the two lab cycling sessions.
* Agree to avoid ingestion of mangoes (fresh or within other products) during the study (other than provided).
Exclusion Criteria:
* Inability to comply with study requirements, history of allergic reactions to mangoes.
* Females: body weight below 110 pounds; pregnant or breastfeeding.
* Any other concurrent condition which, in the opinion of the principle 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).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05409105
Study Brief:
Protocol Section:
NCT05409105