Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2026-01-02 @ 12:51 AM
Study NCT ID:
NCT05350657
Status:
TERMINATED
Last Update Posted:
2023-02-21
First Post:
2021-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketogenic Dietary Patterns in Young Adults and Kidney Health
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Ketogenic Dietary Patterns in Young Adults and Kidney Health
Status:
TERMINATED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 major chronic conditions including diabetes, kidney, cardiac, or liver disease will receive an isocaloric, high protein and low carbohydrate ketogenic diet for 2 weeks.
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 will receive an isocaloric, high protein and low carbohydrate ketogenic diet for 2 weeks. Each participant will consume one meal daily in the Diet and Nutrition (DAN) laboratory metabolic kitchen at the University of Virginia (UVA) and receive the remainder of the daily food allocation packed out to consume at home. Plate-waste method and NDS-R software will be used to measure food consumption (all served and packed-out foods and all uneaten and returned portions will be weighed). Weight, blood pressure and symptom surveys will be monitored at least 3 times a week. Fasting blood and 24 hour urine samples will performed at baseline and the end of each week. Stool for microbiota will be assess at baseline and end of study. Adherence will be confirmed with urinary biomarkers (e.g. urinary nitrogen) and point of care blood testing ketones. Differences in estimated glomerular filtration rate (GFR) determined from serum creatinine and cystatin C will be evaluated for each participant to assess magnitude of increase in GFR on the ketogenic diet. Over the past decade new panels of biomarkers have become available measuring glomerular permeability (urine albumin to creatinine ratio; UACR) and kidney injury and repair (IL-18, kidney injury molecule 1 \[KIM-1\], neutrophil gelatinase-associated lipocalin \[NGAL\], liver fatty acid type binding protein \[L-FABP\], tumor necrosis factor α \[TNF-α, TNF receptor 1 and 2\], transforming growth factor beta \[TGF-β\], human cartilage glycoprotein 39 \[YKL-40\], and monocyte chemoattractant protein 1 \[MCP-1\]). Change in UACR comparing the end of two weeks to baseline will be the primary outcome. Changes in other kidney injury markers will be assessed as secondary and exploratory outcomes. Additional exploratory outcomes will include urine metabolomics and stool 16S rRNA to characterize the gastrointestinal microbiota. Biosamples will be stored in a repository for future uses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: