Ketogenic Diet Health and Longevity (KDHL)

November 27, 2023 updated by: Debra K. Sullivan, PhD, RD, University of Kansas Medical Center

Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment

The goal of this pilot intervention is to learn about how a well-formulated ketogenic diet (WFKD) impacts various health factors in generally healthy adults. The main questions it aims to answer are:

  • Establish whether an 8-week isocaloric, WFKD improves body composition and metabolic biomarkers in adults without chronic disease.
  • Examine changes in transcriptomic sequencing pathways pre- and post-WFKD intervention.
  • Explore gut microbial changes in adults without chronic disease that consume a WFKD.

Participants will follow a well-formulated ketogenic diet for 8-weeks. Study procedures include:

  • Weekly body weight tracking
  • Daily urinary ketone assessment
  • Pre/post stool samples for gut microbiota analyses
  • Pre/post DXA scans
  • Diet quality tracking through 3-day food records

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66208
        • University of Kansas Medical Center

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 30 to 55 years
  • Speaks English as primary language
  • BMI 20.0-34.9 kg/m^2

Exclusion Criteria:

  • Certain medications (statin, blood pressure, thyroid hormone replacement, etc.)
  • Prior medical diagnosis of type 1 or type 2 diabetes mellitus, cancer requiring chemotherapy or radiation therapy within 5 years, cardiac event, GI disorders, traumatic brain injury/multiple concussions, hypertension, dyslipidemia, or any diagnosis deemed ineligible by study team
  • History of renal stones
  • Currently lactating
  • Already following a ketogenic diet
  • Adherence to a specialized diet regimen that disallows compliance
  • Use of tobacco or tobacco replacement products within 1 year

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Well-formulated ketogenic diet (WFKD)
The researchers aim to enroll 20 healthy adults recruited from Kansas City and surrounding areas for an 8-week WFKD diet intervention. Study personnel will obtain baseline (week 0), mid-point (week 4), and end-of-study (8 weeks) blood samples, anthropometrics, and dietary intake data. Fecal microbiome samples and dual energy x-ray absorptiometry (DXA) are collected at baseline and 8-weeks. Blood samples collected at baseline and 8-week visits will be measured for metabolic biomarkers, inflammatory biomarkers, and RNA. The blood sample collected at the 4-week visit will include glucose, insulin, insulin resistance, and beta-hydroxybutyrate to track diet adherence and adjust the diet as needed.
Behavioral: Well-formulated Ketogenic Diet
1:1 ketogenic diet that is focused on intake of high-quality fats (nuts/seeds, fatty fish, avocado) and reduction in processed food.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Body Composition-- dual x-ray absorptiometry (DXA)
Time Frame: Baseline, 8 Week
Measures of tissue distribution
Baseline, 8 Week
Changes in Waist Circumference (WC)
Time Frame: Baseline, 4 Week, 8 Week
Waist circumference (cm)
Baseline, 4 Week, 8 Week
Changes in Body Mass Index (BMI)
Time Frame: Baseline, 4 Week, 8 Week
Ratio of height and weight in kg/m^2
Baseline, 4 Week, 8 Week
Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)
Time Frame: Baseline, 4 Week, 8 Week
Ratio of fasting glucose and fasting insulin with a conversion factor, unitless
Baseline, 4 Week, 8 Week
Changes in Advanced Lipid Panel
Time Frame: Baseline, 8 Week
Baseline, 8 Week
Changes in Inflammation
Time Frame: Baseline, 8 Week
Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)
Baseline, 8 Week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in transcriptomic sequencing pathways
Time Frame: Baseline, 8 weeks
Measured via RNASequencing (RNA-Seq) technique: high-throughput (~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads
Baseline, 8 weeks
Gut microbial changes
Time Frame: Baseline, 8 weeks
Taxonomic classification of individual operational taxonomic units (OTU) with 97% similarity and produce an OTU table of all identified taxa across all samples
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Kansas Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Davis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Debra K Sullivan, PhD, University of Kansas Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 15, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY147643

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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