- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05350657
Ketogenic Dietary Patterns in Young Adults and Kidney Health
February 16, 2023 updated by: Sibylle Kranz, PhD, RDN, University of Virginia
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Faten Hasan
- Phone Number: 434-924-7904
- Email: fh4ua@virginia.edu
Study Locations
-
-
Virginia
-
Charlottesville, Virginia, United States, 22903
- University of Virginia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketogenic Diet
Subjects will be provided with foods following a ketogenic diet for 15 consecutive days.
|
2 week isocaloric, high protein and low carbohydrate ketogenic diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Within-person change in UACR comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Urine Albumin-Creatinine Ratio comparison tested at alpha 0.05
|
Day 0 and day 15 of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Within-person change in eGFR-Cr comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Tested at alpha 0.0125, corrected (Bonferroni correction) for 4 overall outcomes.
Due to very high correlation between different eGFR equations these are not corrected as independent tests
|
Day 0 and day 15 of the intervention
|
Within-person change in eGFR-Cystatin comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Tested at alpha 0.0125, corrected (Bonferroni correction) for 4 overall outcomes.
Due to very high correlation between different eGFR equations these are not corrected as independent tests
|
Day 0 and day 15 of the intervention
|
Within-person change in eGFR-Cr-and-Cystatin comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Tested at alpha 0.0125, corrected (Bonferroni correction) for 4 overall outcomes.
Due to very high correlation between different eGFR equations these are not corrected as independent tests
|
Day 0 and day 15 of the intervention
|
Within-person change in urine KIM-1 comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Tested at alpha 0.0125, corrected (Bonferroni correction) for 4 overall outcomes.
Due to very high correlation between different eGFR equations these are not corrected as independent tests
|
Day 0 and day 15 of the intervention
|
Within-person change in urine NGAL comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Tested at alpha 0.0125, corrected (Bonferroni correction) for 4 overall outcomes.
Due to very high correlation between different eGFR equations these are not corrected as independent tests
|
Day 0 and day 15 of the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Within-person change in MCP-1 comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Exploratory and tested at nominal and false discovery rate (FDR)-adjusted p-values
|
Day 0 and day 15 of the intervention
|
Within person change in urine metabolites comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Exploratory and tested at nominal and false discovery rate (FDR)-adjusted p-values
|
Day 0 and day 15 of the intervention
|
Within person change in microbiome composition by 16s rRNA sequencing comparing Day 15 to pre-intervention
Time Frame: Day 0 and day 15 of the intervention
|
Exploratory and tested at nominal and false discovery rate (FDR)-adjusted p-values
|
Day 0 and day 15 of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Buren J, Ericsson M, Damasceno NRT, Sjodin A. A Ketogenic Low-Carbohydrate High-Fat Diet Increases LDL Cholesterol in Healthy, Young, Normal-Weight Women: A Randomized Controlled Feeding Trial. Nutrients. 2021 Mar 2;13(3):814. doi: 10.3390/nu13030814.
- Cao J, Lei S, Wang X, Cheng S. The Effect of a Ketogenic Low-Carbohydrate, High-Fat Diet on Aerobic Capacity and Exercise Performance in Endurance Athletes: A Systematic Review and Meta-Analysis. Nutrients. 2021 Aug 23;13(8):2896. doi: 10.3390/nu13082896.
- Yancy WS Jr, Westman EC, McDuffie JR, Grambow SC, Jeffreys AS, Bolton J, Chalecki A, Oddone EZ. A randomized trial of a low-carbohydrate diet vs orlistat plus a low-fat diet for weight loss. Arch Intern Med. 2010 Jan 25;170(2):136-45. doi: 10.1001/archinternmed.2009.492. Erratum In: JAMA Intern Med. 2015 Mar;175(3):470.
- Hall KD, Guo J, Courville AB, Boring J, Brychta R, Chen KY, Darcey V, Forde CG, Gharib AM, Gallagher I, Howard R, Joseph PV, Milley L, Ouwerkerk R, Raisinger K, Rozga I, Schick A, Stagliano M, Torres S, Walter M, Walter P, Yang S, Chung ST. Effect of a plant-based, low-fat diet versus an animal-based, ketogenic diet on ad libitum energy intake. Nat Med. 2021 Feb;27(2):344-353. doi: 10.1038/s41591-020-01209-1. Epub 2021 Jan 21.
- Ludwig DS, Willett WC, Volek JS, Neuhouser ML. Dietary fat: From foe to friend? Science. 2018 Nov 16;362(6416):764-770. doi: 10.1126/science.aau2096.
- Mitchell NS, Scialla JJ, Yancy WS Jr. Are low-carbohydrate diets safe in diabetic and nondiabetic chronic kidney disease? Ann N Y Acad Sci. 2020 Feb;1461(1):25-36. doi: 10.1111/nyas.13997. Epub 2019 Jan 15.
- Bostock ECS, Kirkby KC, Taylor BV, Hawrelak JA. Consumer Reports of "Keto Flu" Associated With the Ketogenic Diet. Front Nutr. 2020 Mar 13;7:20. doi: 10.3389/fnut.2020.00020. eCollection 2020.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2022
Primary Completion (Actual)
February 14, 2023
Study Completion (Actual)
February 14, 2023
Study Registration Dates
First Submitted
December 9, 2021
First Submitted That Met QC Criteria
April 21, 2022
First Posted (Actual)
April 28, 2022
Study Record Updates
Last Update Posted (Estimate)
February 20, 2023
Last Update Submitted That Met QC Criteria
February 16, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSR210490
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Kidney Injury
-
Instituto Nacional de Cardiologia Ignacio ChavezInstituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUnknownKidney Injury, Acute | Acute Renal Injury | Acute Kidney Injuries | Kidney Injuries, Acute | Acute Renal InjuriesMexico
-
Mayo ClinicCompletedKidney InjuryUnited States
-
Hospital Medina del CampoCompleted
-
BioPorto DiagnosticsUnknownKidney InjuryUnited States
-
University of PittsburghRenalSense LtdCompletedAcute Kidney Injury | Kidney InjuryUnited States
-
Community Medical Center, Scranton, PACompleted
-
Tel-Aviv Sourasky Medical CenterNot yet recruiting
-
Yonsei UniversityCompletedAcute Kidney Injury(Postoperative Acute Kidney Injury in Patients Undergoing Aortic Surgery)Korea, Republic of
-
University Hospital, GhentWithdrawn
-
University of NottinghamNot yet recruitingKidney Diseases | Ultrasonography | Kidney Injury, Acute | Perfusion ImagingUnited Kingdom
Clinical Trials on Ketogenic Diet
-
Shriners Hospitals for ChildrenUniversity of HawaiiCompleted
-
University of PittsburghBaszucki Brain Research FundRecruitingBipolar DisorderUnited States
-
University of Roma La SapienzaCompleted
-
Kuopio University HospitalDeakin UniversityRecruitingPsychotic Disorders | Schizophrenia | Psychosis | Psychosis; AcuteFinland
-
Mid-Atlantic Epilepsy and Sleep Center, LLCUnknown
-
University of FloridaRecruitingSeizuresUnited States
-
Helse Nord-Trøndelag HFNorwegian University of Science and Technology; Vanderbilt University Medical... and other collaboratorsActive, not recruiting
-
University of Maryland, BaltimoreRecruiting
-
Ohio State UniversityRecruiting
-
University of PadovaUniversity of Palermo; Universidade Federal de GoiasCompleted