Clinical trial NCT05939011: Ketogenic Diet Health and Longevity
Official title: Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketogenic Dieting
Ketoses, Metabolic
Ketosis
Keywords: ketogenic
well-formulated ketogenic diet
keto
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: University of California, Davis
First posted: 2023-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, pilot clinical trial
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Body Composition-- dual x-ray absorptiometry (DXA)
timeFrame: Baseline, 8 Week
measure: Changes in Waist Circumference (WC)
timeFrame: Baseline, 4 Week, 8 Week
measure: Changes in Body Mass Index (BMI)
timeFrame: Baseline, 4 Week, 8 Week
measure: Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)
timeFrame: Baseline, 4 Week, 8 Week
measure: Changes in Advanced Lipid Panel
timeFrame: Baseline, 8 Week
measure: Changes in Inflammation
timeFrame: Baseline, 8 Week
Secondary outcomes:
measure: Changes in transcriptomic sequencing pathways
timeFrame: Baseline, 8 weeks
measure: Gut microbial changes
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Debra K Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
References: