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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT05675956
Eligibility Criteria:
Inclusion Criteria:
* Participant is between 18-30 BMI.
* Participant needs to be either an ROTC member, currently employed military or law enforcement officer or are a military veteran or retired law enforcement officer who has completed service in the past 18 months.
* Participant has provided written and dated informed consent.
* Participant is in good health and able to participate in high-intensity exercise.
* Participant have been clinically diagnosed with a concussion at least 3 months prior to screening and is asymptomatic.
* Participant is willing to maintain their current dietary supplement usage through the duration of the study. If the participant began taking another supplement within the past month, the participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation.
Exclusion Criteria:
* Participant with any musculoskeletal injuries that would prevent exercising.
* Participant with any metabolic disorder including known electrolyte abnormalities, diabetes, thyroid disease, adrenal disease or hypogonadism.
* Participant with a history of hepatorenal, musculoskeletal, or autoimmune disease.
* Participant with a personal history of heart disease, cardiovascular conditions, high blood pressure (systolic \>140 mm Hg \& diastolic \>90 mm Hg), psychiatric disorders, neurological disorders, developmental disorders, cancer, benign prostate hypertrophy, gastric ulcer, reflux disease, or any other medical condition (i.e. visual/auditory) deemed exclusionary by the medical staff.
* Participant currently taking medication that affects the ANS such as thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, anticoagulant, or psychotropic medications, or antihistamines.
* Participant who is pregnant or lactating.
* Participant with any of the following concussion characteristics; history of \>3 concussions, loss of consciousness (\>5 minutes), cause of injury related to violence e.g. physical altercations.
* Participants with a history of moderate to severe TBI.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05675956
Study Brief:
Protocol Section:
NCT05675956