Ketogenic Diet Health and Longevity

Ketosis Clinical Trial

— KDHL  

Official title:

Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05939011
• Other study ID #: STUDY147643
• Status: Completed
• Phase: N/A
• Start date: April 8, 2022
• Est. completion date: September 15, 2023

Study information

• Verified date: November 2023
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketogenic Dieting
• Ketoses, Metabolic
• Ketosis

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Body Composition-- dual x-ray absorptiometry (DXA)	Measures of tissue distribution	Baseline, 8 Week
Primary	Changes in Waist Circumference (WC)	Waist circumference (cm)	Baseline, 4 Week, 8 Week
Primary	Changes in Body Mass Index (BMI)	Ratio of height and weight in kg/m^2	Baseline, 4 Week, 8 Week
Primary	Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)	Ratio of fasting glucose and fasting insulin with a conversion factor, unitless	Baseline, 4 Week, 8 Week
Primary	Changes in Advanced Lipid Panel		Baseline, 8 Week
Primary	Changes in Inflammation	Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)	Baseline, 8 Week
Secondary	Changes in transcriptomic sequencing pathways	Measured via RNASequencing (RNA-Seq) technique: high-throughput (~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads	Baseline, 8 weeks
Secondary	Gut microbial changes	Taxonomic classification of individual operational taxonomic units (OTU) with 97% similarity and produce an OTU table of all identified taxa across all samples	Baseline, 8 weeks