Ketogenic Diet Health and Longevity

Study Overview
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Brief Summary
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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

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

Conditions
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Ketogenic Dieting, Ketoses, Metabolic, Ketosis

Intervention / Treatment
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* Behavioral: Well-formulated Ketogenic Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm, pilot clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Well-formulated ketogenic diet (WFKD)<br>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<br>* 1:1 ketogenic diet that is focused on intake of high-quality fats (nuts/seeds, fatty fish, avocado) and reduction in processed food.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ketogenic, well-formulated ketogenic diet, keto