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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT06392360
Eligibility Criteria:
Inclusion Criteria:
* Male or female cyclists, ages 18-65 years, and capable of cycling 60-km in the laboratory at 70% VO2max (close to race pace).
* Non-smoker, and generally healthy and without gastrointestinal diseases (irritable bowel syndrome, chronic nausea, vomiting, and diarrhea, Crohn's disease, Celiac disease, diverticulosis) or chronic diseases 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 2 lab cycling sessions.
* Agree to restrict beet, wheat bran, wheat germ, and spinach diet intake and avoid other betaine supplements (other than what is provided in the supplement) during the entire 6-week study.
Exclusion Criteria:
* Inability to comply with study requirements.
* Females trying to become pregnant, or currently pregnant or breastfeeding.
* Nonpregnant adults who weigh less than 110 pounds.
* 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 gastrointestinal disease, cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
* History of sensitivity to betaine and beets.
* History of adverse symptoms to lactulose, mannitol, and rhamnose sugars.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06392360
Study Brief:
Protocol Section:
NCT06392360