Ketogenic Diet Health and Longevity (KDHL)

University of Kansas

Status: Completed

Conditions: Ketosis; Ketoses, Metabolic; Ketogenic Dieting

Treatments: Behavioral: Well-formulated Ketogenic Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05939011

STUDY147643

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Well-formulated ketogenic diet (WFKD)

Experimental group

Description:

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.

Treatment:

Behavioral: Well-formulated Ketogenic Diet