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| Name | Class |
|---|---|
| University of California, Davis | OTHER |
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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:
Participants will follow a well-formulated ketogenic diet for 8-weeks. Study procedures include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Well-formulated ketogenic diet (WFKD) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Well-formulated Ketogenic Diet | Behavioral | 1:1 ketogenic diet that is focused on intake of high-quality fats (nuts/seeds, fatty fish, avocado) and reduction in processed food. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra K Sullivan, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66208 | United States |
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| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Single-arm, pilot clinical trial
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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 |