NCT05350657

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

10 months

First QC Date

December 9, 2021

Last Update Submit

February 16, 2023

Conditions

Ketogenic DietKidney Injury

Keywords

ketogenic dietkidney injury

Outcome Measures

Primary Outcomes (1)

  • Within-person change in UACR comparing Day 15 to pre-intervention

    Urine Albumin-Creatinine Ratio comparison tested at alpha 0.05

    Day 0 and day 15 of the intervention

Secondary Outcomes (5)

  • Within-person change in eGFR-Cr comparing Day 15 to pre-intervention

    Day 0 and day 15 of the intervention

  • Within-person change in eGFR-Cystatin comparing Day 15 to pre-intervention

    Day 0 and day 15 of the intervention

  • Within-person change in eGFR-Cr-and-Cystatin comparing Day 15 to pre-intervention

    Day 0 and day 15 of the intervention

  • Within-person change in urine KIM-1 comparing Day 15 to pre-intervention

    Day 0 and day 15 of the intervention

  • Within-person change in urine NGAL comparing Day 15 to pre-intervention

    Day 0 and day 15 of the intervention

Other Outcomes (3)

  • Within-person change in MCP-1 comparing Day 15 to pre-intervention

    Day 0 and day 15 of the intervention

  • Within person change in urine metabolites comparing Day 15 to pre-intervention

    Day 0 and day 15 of the intervention

  • Within person change in microbiome composition by 16s rRNA sequencing comparing Day 15 to pre-intervention

    Day 0 and day 15 of the intervention

Study Arms (1)

Ketogenic Diet

EXPERIMENTAL

Subjects will be provided with foods following a ketogenic diet for 15 consecutive days.

Behavioral: Ketogenic Diet

Interventions

Ketogenic DietBEHAVIORAL

2 week isocaloric, high protein and low carbohydrate ketogenic diet

Ketogenic Diet

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (7)

  • 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.

    PMID: 33801247BACKGROUND

  • 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.

    PMID: 34445057BACKGROUND

  • 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.

    PMID: 20101008BACKGROUND

  • 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.

    PMID: 33479499BACKGROUND

  • 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.

    PMID: 30442800BACKGROUND

  • 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.

    PMID: 30644556BACKGROUND

  • 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.

    PMID: 32232045BACKGROUND

MeSH Terms

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-RestrictedDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Sibylle Kranz, PhD RDN FTOS

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 9, 2021

First Posted

April 28, 2022

Study Start

May 1, 2022

Primary Completion

February 14, 2023

Study Completion

February 14, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Locations

US(1)