Ketogenic DietNCT05350657
Ketogenic Dietary Patterns in Young Adults and Kidney Health
A study testing Ketogenic Diet in people with Ketogenic Diet and Kidney Injury, run by University of Virginia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Diet, Kidney Injury
- What is being tested?
- Ketogenic Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 14 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
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.
Read the 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.
- Conditions
- Ketogenic Diet, Kidney Injury
- Being tested
- Ketogenic Diet
- Keywords
- ketogenic diet, kidney injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietBehavioural
2 week isocaloric, high protein and low carbohydrate ketogenic diet
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Experimental | Subjects will be provided with foods following a ketogenic diet for 15 consecutive days. Receives: Behavioral: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-person change in UACR comparing Day 15 to pre-intervention
Urine Albumin-Creatinine Ratio comparison tested at alpha 0.05
Measured: Day 0 and day 15 of the intervention
Secondary outcomes (5)
Within-person change in eGFR-Cr comparing Day 15 to pre-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
Measured: Day 0 and day 15 of the intervention
Within-person change in eGFR-Cystatin comparing Day 15 to pre-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
Measured: Day 0 and day 15 of the intervention
Within-person change in eGFR-Cr-and-Cystatin comparing Day 15 to pre-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
Measured: Day 0 and day 15 of the intervention
Within-person change in urine KIM-1 comparing Day 15 to pre-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
Measured: Day 0 and day 15 of the intervention
Within-person change in urine NGAL comparing Day 15 to pre-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
Measured: Day 0 and day 15 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 May 2022
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ketogenic DietStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibylle Kranz, PhD, RDN, University of Virginia
- Investigators
- Sibylle Kranz, PhD RDN FTOS, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350657
- Sponsor's protocol ID
- HSR210490
- Status last verified
- Feb 2023
- First submitted
- 9 Dec 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 33801247Cao 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.
PubMed 34445057Yancy 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.
PubMed 20101008Hall 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.
PubMed 33479499Ludwig 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.
PubMed 30442800Mitchell 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.
PubMed 30644556Bostock 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.
PubMed 32232045
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketogenic Dietary Patterns in Young Adults and Kidney Health
- ClinicalTrials.gov ID
- NCT05350657
- Acronym / sponsor ID
- HSR210490
- Conditions
- Ketogenic Diet, Kidney Injury
- Keywords
- ketogenic diet, kidney injury
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Experimental | Behavioral: Ketogenic DietSubjects will be provided with foods following a ketogenic diet for 15 consecutive days. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketogenic Diet2 week isocaloric, high protein and low carbohydrate ketogenic diet | Behavioural | Ketogenic Diet |
Primary outcome
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
5 secondary outcomes
Within-person change in eGFR-Cr comparing Day 15 to pre-intervention
Time frame: 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
Within-person change in eGFR-Cr-and-Cystatin comparing Day 15 to pre-intervention
Time frame: 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
Within-person change in urine NGAL comparing Day 15 to pre-intervention
Time frame: Day 0 and day 15 of the intervention
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Background: PubMed 33801247Buren 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.
- Background: PubMed 34445057Cao 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.
- Background: PubMed 20101008Yancy 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.
- Background: PubMed 33479499Hall 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.
- Background: PubMed 30442800Ludwig 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.
- Background: PubMed 30644556Mitchell 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.
- Background: PubMed 32232045Bostock 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.
Related trials for Ketogenic Diet
Not yet recruiting
Ketone Ester for Treatment Of Acute Heart Failure
Acute Heart Failure
Active, not recruiting
Effects of Short-term Adaptation to Ketogenic Diet on Endurance Trained Athletes
Ketogenic Diet, Control Condition
Recruiting
Well-Formulated Ketogenic Diet Polycystic Kidney Disease
Polycystic Kidney Disease
Not yet recruiting
GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma
Recurrent Glioma (Glioblastoma Multiforme)
Recruiting
Ketogenic Diet and Neuromodulation in Treatment Resistant Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression (TRD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibylle Kranz, PhD RDN FTOS principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet in people with Ketogenic Diet and Kidney Injury, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-person change in UACR comparing Day 15 to pre-intervention (time frame: Day 0 and day 15 of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05350657, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.