Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2022-04-08
2023-09-15
Brief Summary
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* 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
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Speaks English as primary language
* BMI 20.0-34.9 kg/m\^2
Exclusion Criteria
* 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
30 Years
55 Years
ALL
Yes
Sponsors
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University of California, Davis
OTHER
University of Kansas Medical Center
OTHER
Responsible Party
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Debra K. Sullivan, PhD, RD
Department Chair, Dietetics and Nutrition
Principal Investigators
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Debra K Sullivan, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Other Identifiers
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STUDY147643
Identifier Type: -
Identifier Source: org_study_id