Ketogenic Diet Health and Longevity
- Conditions
- Ketogenic DietingKetoses, MetabolicKetosis
- Interventions
- Behavioral: Well-formulated Ketogenic Diet
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 30 to 55 years
- Speaks English as primary language
- BMI 20.0-34.9 kg/m^2
- 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
- Arm && Interventions
Group Intervention Description Well-formulated ketogenic diet (WFKD) Well-formulated Ketogenic Diet 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.
- Primary Outcome Measures
Name Time Method 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
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)
- 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