An interventional study of Well-formulated Ketogenic Diet in Ketogenic Dieting, Ketoses, Metabolic and Ketosis, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-28.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Prevention
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:
Participants will follow a well-formulated ketogenic diet for 8-weeks. Study procedures include:
181 studies on the registry are indexed under Ketosis; 37 are open to participants now.
This study's enrollment of 20 is below the median of 25 across 144 interventional studies indexed under Ketosis.
Browse Ketosis studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Changes in Body Composition-- dual x-ray absorptiometry (DXA)
Measures of tissue distribution
Time frame: Baseline, 8 Week
Changes in Waist Circumference (WC)
Waist circumference (cm)
Time frame: Baseline, 4 Week, 8 Week
Changes in Body Mass Index (BMI)
Ratio of height and weight in kg/m\^2
Time frame: 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
Time frame: Baseline, 4 Week, 8 Week
Changes in Advanced Lipid Panel
Time frame: Baseline, 8 Week
Changes in Inflammation
Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)
Time frame: Baseline, 8 Week
Changes in transcriptomic sequencing pathways
Measured via RNASequencing (RNA-Seq) technique: high-throughput (\~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads
Time frame: 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
Time frame: Baseline, 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center