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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT05907135
Eligibility Criteria:
Inclusion Criteria:
* Male or female cyclists, ages 18-60 years, and capable of cycling 2.25 h in the laboratory 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 limit intake of nitrate-rich vegetables during the study to less than 1 cup per day. These include spinach, lettuce, beets, beetroot juice, celery, and cabbage.
* Agree to taper their exercise routine prior to each of the two lab cycling sessions.
* Agree to avoid the use of mouthwashes, antacids, and chewing gum during the entire 6-week study and the 2-week period prior to the study.
Exclusion Criteria:
* Inability to comply with study requirements.
* Females: body weight below 110 pounds; trying to become pregnant, pregnant or breastfeeding.
* Any other concurrent condition which, in the opinion of the principal 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).
* An unwillingness to avoid mouthwashes, antacids, and chewing gum 2 weeks before and during the 6-week study.
* An unwillingness to limit intake of nitrate-rich vegetables 2 weeks before and during the 6-week study.
* Current history of uncontrolled hypertension and/or the use of vasodilatory medications.
* Sensitivity to caffeine intake from green tea extract (200 mg per day).
* History of allergic reactions to any of the ingredients in the study supplement: beet powder, camu camu, green tea extract, mushroom blend (caterpillar fungus, lion's mane, chaga), quinoa sprouts, monk fruit, pineapple, cranberry seed powder, strawberry fruit powder).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05907135
Study Brief:
Protocol Section:
NCT05907135