Ketogenic Dieting, Ketoses, Metabolic, Ketosis
Conditions
Keywords
ketogenic, well-formulated ketogenic diet, keto
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
Interventions
BEHAVIORALWell-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.
Sponsors
University of California, Davis
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Single-arm, pilot clinical trial
Eligibility
Sex/Gender
ALL
Age
30 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Inflammation | Baseline, 8 Week | Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L) |
| 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 Advanced Lipid Panel | Baseline, 8 Week | — |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed