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Ketogenic Diet Health and Longevity (KDHL)

Primary Purpose

Ketogenic Dieting, Ketoses, Metabolic, Ketosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Well-formulated Ketogenic Diet
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ketogenic Dieting focused on measuring ketogenic, well-formulated ketogenic diet, keto

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Well-formulated ketogenic diet (WFKD)

Arm Description

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.

Outcomes

Primary Outcome Measures

Changes in Body Composition-- dual x-ray absorptiometry (DXA)
Measures of tissue distribution
Changes in Waist Circumference (WC)
Waist circumference (cm)
Changes in Body Mass Index (BMI)
Ratio of height and weight in kg/m^2
Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)
Ratio of fasting glucose and fasting insulin with a conversion factor, unitless
Changes in Advanced Lipid Panel
Changes in Inflammation
Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)

Secondary Outcome Measures

Changes in transcriptomic sequencing pathways
Measured via RNASequencing (RNA-Seq) technique: high-throughput (~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads
Gut microbial changes
Taxonomic classification of individual operational taxonomic units (OTU) with 97% similarity and produce an OTU table of all identified taxa across all samples

Full Information

First Posted
February 10, 2023
Last Updated
July 13, 2023
Sponsor
University of Kansas Medical Center
Collaborators
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT05939011
Brief Title
Ketogenic Diet Health and Longevity
Acronym
KDHL
Official Title
Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 8, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
Collaborators
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketogenic Dieting, Ketoses, Metabolic, Ketosis
Keywords
ketogenic, well-formulated ketogenic diet, keto

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm, pilot clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Well-formulated ketogenic diet (WFKD)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Well-formulated Ketogenic Diet
Intervention Description
1:1 ketogenic diet that is focused on intake of high-quality fats (nuts/seeds, fatty fish, avocado) and reduction in processed food.
Primary Outcome Measure Information:
Title
Changes in Body Composition-- dual x-ray absorptiometry (DXA)
Description
Measures of tissue distribution
Time Frame
Baseline, 8 Week
Title
Changes in Waist Circumference (WC)
Description
Waist circumference (cm)
Time Frame
Baseline, 4 Week, 8 Week
Title
Changes in Body Mass Index (BMI)
Description
Ratio of height and weight in kg/m^2
Time Frame
Baseline, 4 Week, 8 Week
Title
Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)
Description
Ratio of fasting glucose and fasting insulin with a conversion factor, unitless
Time Frame
Baseline, 4 Week, 8 Week
Title
Changes in Advanced Lipid Panel
Time Frame
Baseline, 8 Week
Title
Changes in Inflammation
Description
Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)
Time Frame
Baseline, 8 Week
Secondary Outcome Measure Information:
Title
Changes in transcriptomic sequencing pathways
Description
Measured via RNASequencing (RNA-Seq) technique: high-throughput (~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads
Time Frame
Baseline, 8 weeks
Title
Gut microbial changes
Description
Taxonomic classification of individual operational taxonomic units (OTU) with 97% similarity and produce an OTU table of all identified taxa across all samples
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra K Sullivan, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ketogenic Diet Health and Longevity

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