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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06300060
Eligibility Criteria:
Inclusion Criteria:
* Male or female between the ages of 18-45
* Currently cycling for at least 3 hours per week for the past 3 months
* Free of any contraindications to exercise and any medical condition that could interfere with or influence metabolic or cardiovascular responses to exercise
* Have a resting heart rate \<100 bpm and resting systolic and diastolic blood pressures \<160 mmHg and \<90 mmHg, respectively.
Exclusion Criteria:
* Use of antibiotics or probiotic products within 4 weeks prior to study enrollment (note: participants will be eligible after a 2-week washout period)
* Current laxative use
* Are a smoker or use tobacco products
* Consume \>21 units of alcohol per week
* Have donated blood in the previous 3 months
* Have a BMI ≥30kg/m2
* Are pregnant or lactating or planning to become pregnant for the duration of the study
* Are dieting for weight loss or are following a low carbohydrate diet
* Have participated in another clinical trial within the 30 days preceding study enrollment
* Are taking medications known to affect cardiovascular or metabolic responses to exercise
* Have a medical condition that could interfere with study intervention and assessment
* Have current musculoskeletal injuries that limit exercise capacity
* Are non-English speaking
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06300060
Study Brief:
Protocol Section:
NCT06300060