Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Changes in Advanced Lipid Panel
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 55 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Well-formulated ketogenic diet (WFKD)
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.
Intervention: Well-formulated Ketogenic Diet (Behavioral)
Outcomes
Primary Outcomes
Changes in Advanced Lipid Panel
Time Frame: Baseline, 8 Week
Changes in Body Composition-- dual x-ray absorptiometry (DXA)
Time Frame: Baseline, 8 Week
Measures of tissue distribution
Changes in Waist Circumference (WC)
Time Frame: Baseline, 4 Week, 8 Week
Waist circumference (cm)
Changes in Body Mass Index (BMI)
Time Frame: Baseline, 4 Week, 8 Week
Ratio of height and weight in kg/m\^2
Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)
Time Frame: Baseline, 4 Week, 8 Week
Ratio of fasting glucose and fasting insulin with a conversion factor, unitless
Changes in Inflammation
Time Frame: Baseline, 8 Week
Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)
Secondary Outcomes
- Changes in transcriptomic sequencing pathways(Baseline, 8 weeks)
- Gut microbial changes(Baseline, 8 weeks)
Investigators
Debra K. Sullivan, PhD, RD
Department Chair, Dietetics and Nutrition
University of Kansas Medical Center