Status:
TERMINATED
Ketogenic Dietary Patterns in Young Adults and Kidney Health
Lead Sponsor:
University of Virginia
Conditions:
Ketogenic Diet
Kidney Injury
Eligibility:
All Genders
20-40 years
Phase:
NA
Brief Summary
This study seeks to assess the kidney health effects of short-term healthful ketogenic diet in young, overweight adults.10 overweight (BMI 25-30 kg/m2) adult participants (ages 20-40 years) without ma...
Detailed Description
After baseline measures are taken, 10 overweight (BMI 25-30 kg/m2) young adult participants (ages 20-40 years) without major chronic conditions including diabetes, kidney, cardiac, or liver disease wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05350657
Start Date
May 1 2022
End Date
February 14 2023
Last Update
February 21 2023
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903