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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT06733532
Eligibility Criteria:
Inclusion Criteria:
* body mass index (BMI) \<35 kg/m2 (not morbidly obese)
* Cannot have a sensitivity or be allergic to any components of the study product they will be excluded.
* non-tobacco user
* cannot be following a specialized dietary pattern that may alter findings (e.g., low carbohydrate/ketogenic diet, carnivore diet, intermittent fasting etc.)
* willing to replicate the same dietary intake/activity (exercise) level for each day before a lab visit excluding screening
* Will consume a minimum of 2 liters (women) or 2.5 liters (men) of water per day, on each day prior to experimental lab visits (excluding screening)
* Will arrive to lab for visits euhydrated (USG 1.005-1.020)
* Will not consume alcohol-containing beverages within 24 hours of testing
* Will not consume caffeine-containing beverages within 12 hours of testing
* can fast (consume water/treatments only) for 15 hours (10 hours prior to lab visits not including screening)
* avoid strenuous activity for 24 hours prior to study visits excluding screening
* Will not have a history or presence of a clinically relevant (that required or requires treatment) cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, biliary, gastrointestinal, pancreatic, or neurologic disorder (reviewed by Nurse practitioner)
* Will not have other conditions that is likely to alter fluid balance or be negatively affected by changing electrolyte levels/hydration status (as determined by Nurse practitioner)
* Is not consuming any medication which may alter fluid retention/electrolyte levels such as sodium-glucose co-transporter 2 (SGLT2) inhibitor (for type 2 diabetes), laxatives, diuretics, Apremilast, chemotherapy, or lithium. (Medications will be reviewed by Nurse practitioner)
* Will not consume nutritional supplements, performance enhancing drugs, and/or non-steroidal anti-inflammatory drugs within 7 days of study visits excluding screening.
* cannot be enrolled in another clinical study within 30 days of the first study visit
* without active infection or illness of any kind
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06733532
Study Brief:
Protocol Section:
NCT06733532