Ketogenic Diet Health and Longevity (KDHL)

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: Completed
• Conditions: Ketosis; Ketoses, Metabolic; Ketogenic Dieting
• Intervention / Treatment: Behavioral: Well-formulated Ketogenic Diet

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Changes in Body Composition-- dual x-ray absorptiometry (DXA)	Measures of tissue distribution	Baseline, 8 Week
Changes in Waist Circumference (WC)	Waist circumference (cm)	Baseline, 4 Week, 8 Week
Changes in Body Mass Index (BMI)	Ratio of height and weight in kg/m^2	Baseline, 4 Week, 8 Week
Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)	Ratio of fasting glucose and fasting insulin with a conversion factor, unitless	Baseline, 4 Week, 8 Week
Changes in Advanced Lipid Panel		Baseline, 8 Week
Changes in Inflammation	Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)	Baseline, 8 Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in transcriptomic sequencing pathways	Measured via RNASequencing (RNA-Seq) technique: high-throughput (~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads	Baseline, 8 weeks
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	Baseline, 8 weeks

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: University of California, Davis
• Investigators: Principal Investigator: Debra K Sullivan, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2022
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ketogenic; keto; well-formulated ketogenic diet
• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis
• Other Study ID 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