Ketogenic Diet Health and Longevity

Not Applicable

Completed

• Conditions: Ketogenic Dieting; Ketoses, Metabolic; Ketosis

• Registration Number: NCT05939011
• Lead Sponsor: University of Kansas Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-08
• Study First Submitted: 2023-02-10
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-11
• Primary Completion: 2023-09-15
• Study Completion: 2023-09-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in Body Composition-- dual x-ray absorptiometry (DXA)	Baseline, 8 Week	Measures of tissue distribution
Changes in Waist Circumference (WC)	Baseline, 4 Week, 8 Week	Waist circumference (cm)
Changes in Body Mass Index (BMI)	Baseline, 4 Week, 8 Week	Ratio of height and weight in kg/m\^2
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
Changes in Inflammation	Baseline, 8 Week	Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)
Changes in Advanced Lipid Panel	Baseline, 8 Week

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States