KDHL: Ketogenic Diet Health and Longevity

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05939011
• Collaborator: University of California, Davis (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 16.8
• Patients Per Site Per Month: 1.2

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Ketogenic Dieting; Ketoses, Metabolic; Ketosis	Behavioral: Well-formulated Ketogenic Diet	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Single-arm, pilot clinical trialSingle-arm, pilot clinical trial
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment
• Actual Study Start Date: Apr 8, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes in Body Composition-- dual x-ray absorptiometry (DXA) [Baseline, 8 Week]

   Measures of tissue distribution

2. Changes in Waist Circumference (WC) [Baseline, 4 Week, 8 Week]

   Waist circumference (cm)

3. Changes in Body Mass Index (BMI) [Baseline, 4 Week, 8 Week]

   Ratio of height and weight in kg/m^2

4. Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR) [Baseline, 4 Week, 8 Week]

   Ratio of fasting glucose and fasting insulin with a conversion factor, unitless

5. Changes in Advanced Lipid Panel [Baseline, 8 Week]

6. Changes in Inflammation [Baseline, 8 Week]

   Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)

Secondary Outcome Measures

1. Changes in transcriptomic sequencing pathways [Baseline, 8 weeks]

   Measured via RNASequencing (RNA-Seq) technique: high-throughput (~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads

2. Gut microbial changes [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66208

Sponsors and Collaborators

• University of Kansas Medical Center
• University of California, Davis

Investigators

• Principal Investigator: Debra K Sullivan, PhD, University of Kansas Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Debra K. Sullivan, PhD, RD, Department Chair, Dietetics and Nutrition, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT05939011
• Other Study ID Numbers: STUDY147643
• First Posted: Jul 11, 2023
• Last Update Posted: Jul 14, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Debra K. Sullivan, PhD, RD, Department Chair, Dietetics and Nutrition, University of Kansas Medical Center: ketogenic; well-formulated ketogenic diet; keto
• Additional relevant MeSH terms: Ketosis

Study Results

No Results Posted as of Jul 14, 2023