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 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT05350657
Eligibility Criteria:
Inclusion Criteria:
* Overweight (BMI 25-30 kg/m2)
* Weight stable for last 4 weeks by self-report
* Residing in the greater Charlottesville/Albemarle area for \>6 months out of the last year
* Normal kidney function at baseline, eGFR ≥60 ml/min/1.73m2 and UACR \<30 mg/g at screening
Exclusion Criteria:
* History of major medical comorbidities by self-report (history of diabetes; diagnosed kidney disease; diagnosed gastrointestinal disorders including inflammatory bowel disease, gastric bypass, intestinal resection, celiac disease or other malabsorption; esophageal or other disorders limiting ability to swallow food)
* Systolic blood pressure \>160 or \<100 at screening
* Daily use of diuretics such as hydrochlorothiazide
* Serum potassium \<3.5 or \>5.1 mEq/L at screening
* Serum magnesium \<1.6 mg/dL at screening
* Serum sodium \<135 or \>149 mEq/L at screening
* HbA1c \> 6.5% at screening
* Fasting plasma glucose \> 126 mg/dL at screening
* Pregnant or breastfeeding women (confirmed by spot urine at screening)
* Inability to give written informed consent in English
* Inability to walk up to 1 mile at a slow pace between buildings for study visits
* Food allergies
* Eating ketogenic or low carbohydrate diet over last 4 weeks
* Blood ketones positive at screening
* Intolerance or dislike of any study foods limiting adherence
* Inability to attend daily visits
* Vulnerable population such as direct reports or students of the investigators
* Lack of access to refrigeration or equipment to safely reheat meals
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT05350657
Study Brief:
Protocol Section:
NCT05350657