Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05939011
Other study ID # STUDY147643
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04477161 - Effect of Ketone Esters in Parkinson's Disease N/A
Active, not recruiting NCT05477368 - Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes N/A
Completed NCT04817176 - MI-CBT Adherence Program for Lifestyle Interventions in Older Adults Early Phase 1
Completed NCT04565444 - Ketones and Muscle Protein Synthesis N/A
Not yet recruiting NCT06418074 - Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity N/A
Not yet recruiting NCT03954665 - Ketone Supplementation and Exercise Performance N/A
Active, not recruiting NCT06097754 - Intermittent Exogenous Ketosis (IEK) at High Altitude N/A
Terminated NCT03790436 - Betaquik as an Adjunct to Dietary Management of Epilepsy in Adults on the Modified Atkins Diet N/A
Completed NCT03299543 - Comparison Between Breath Acetone and Blood Beta-Hydroxybutyrate
Recruiting NCT04004676 - Ketone Supplementation, Glycogen Replenishment and Time Trial Performance Following Glycogen Lowering Exercise N/A
Not yet recruiting NCT03659825 - Ketone Esters for Optimization of Cognitive Performance in Hypoxia N/A
Active, not recruiting NCT04156477 - Markers of Appetite Regulation During Exogenous Ketosis N/A
Completed NCT04130724 - Characterization of a Portable Solid-State Breath Acetone Testing Device for Real-Time Ketosis Status
Recruiting NCT04594265 - Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure Phase 2
Not yet recruiting NCT04576026 - Exogenous Ketone Supplementation and Cognitive Function During Exercise N/A
Completed NCT05558488 - The Effect of a Meatless,Keto Restrictive Diet on Body Composition,Strength Capacity,Oxidative Stress,Immune Response N/A
Recruiting NCT03564002 - Metabolic Effects of Very Low Carbohydrate Ketogenic Diet in Subjects With Severe Obesity
Completed NCT04309214 - Market Research - Acceptability Study for New MCT Fat Products N/A
Completed NCT05588427 - Effect of Ketone Ester Supplementation on Hypoxic Tolerance N/A
Recruiting NCT05656339 - Metabolic Effects of Whey Protein Supplementation After Fasting in Volunteers N/A