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Behavioral Intervention
Well-formulated ketogenic diet (WFKD) for Ketosis (KDHL Trial)
N/A
Waitlist Available
Led By Debra K Sullivan, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 week, 8 week
Awards & highlights
KDHL Trial Summary
This trial will explore how a well-formulated ketogenic diet affects body composition and metabolic biomarkers in healthy adults.
Eligible Conditions
- Ketosis
- Metabolic Syndrome
- Ketogenic Diet
KDHL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4 week, 8 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 week, 8 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Advanced Lipid Panel
Changes in Body Composition-- dual x-ray absorptiometry (DXA)
Changes in Body Mass Index (BMI)
+3 moreSecondary outcome measures
Changes in transcriptomic sequencing pathways
Gut microbial changes
KDHL Trial Design
1Treatment groups
Experimental Treatment
Group I: Well-formulated ketogenic diet (WFKD)Experimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Well-formulated Ketogenic Diet
2022
N/A
~20
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,137 Total Patients Enrolled
University of California, DavisOTHER
910 Previous Clinical Trials
4,706,971 Total Patients Enrolled
2 Trials studying Ketosis
1,409 Patients Enrolled for Ketosis
Debra K Sullivan, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the age-range for this research study restricted to individuals aged 55 or older?
"Per the entry requirements for this experiment, only persons aged 30 to 55 are permitted to participate."
Answered by AI
What are the eligibility requirements for individuals seeking to join this clinical experiment?
"This medical trial seeks 20 individuals with ketosis between the ages of 30 and 55. Criteria for applicants includes English fluency, as well as a Body Mass Index (BMI) within the range of 20-34.9 kg/m^2."
Answered by AI
Could you provide information about the enrollment process for this trial?
"Evidence posted on clinicaltrials.gov suggests that this particular trial, which was initially established on April 8th 2022, is not actively recruiting patients right now. However, 33 other studies are currently searching for participants."
Answered by AI
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