Ketogenic DietingKDHLNCT05939011
Ketogenic Diet Health and Longevity
A study testing Well-formulated Ketogenic Diet in people with Ketogenic Dieting and Ketoses, Metabolic, run by University of Kansas Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Ketogenic Dieting, Ketoses, Metabolic, Ketosis
- What is being tested?
- Well-formulated Ketogenic Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30 to 55 years
- Speaks English as primary language
- BMI 20.0-34.9 kg/m^2
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66208
About this study
Official title: Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment
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.
Read more
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
- Conditions
- Ketogenic Dieting, Ketoses, Metabolic, Ketosis
- Being tested
- Well-formulated Ketogenic Diet
- Keywords
- ketogenic, well-formulated ketogenic diet, keto
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Well-formulated Ketogenic DietBehavioural
1:1 ketogenic diet that is focused on intake of high-quality fats (nuts/seeds, fatty fish, avocado) and reduction in processed food.
| Study group | Role | What they receive |
|---|---|---|
| Well-formulated ketogenic diet (WFKD) | Experimental | 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. Receives: Behavioral: Well-formulated Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Body Composition-- dual x-ray absorptiometry (DXA)
Measures of tissue distribution
Measured: Baseline, 8 Week
Changes in Waist Circumference (WC)
Waist circumference (cm)
Measured: Baseline, 4 Week, 8 Week
Changes in Body Mass Index (BMI)
Ratio of height and weight in kg/m^2
Measured: Baseline, 4 Week, 8 Week
Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)
Ratio of fasting glucose and fasting insulin with a conversion factor, unitless
Measured: Baseline, 4 Week, 8 Week
Changes in Advanced Lipid Panel
Measured: Baseline, 8 Week
Changes in Inflammation
Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)
Measured: Baseline, 8 Week
Secondary outcomes (2)
Changes in transcriptomic sequencing pathways
Measured via RNASequencing (RNA-Seq) technique: high-throughput (~25,000 genes) RNAseq using SE100 Illumina (HiSeq) reads
Measured: Baseline, 8 weeks
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
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start8 Apr 2022
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ketogenic DietingStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, pilot clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis
- Responsible party
- Principal investigator, Debra K. Sullivan, PhD, RD, University of Kansas Medical Center
- Investigators
- Debra K Sullivan, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939011
- Sponsor's protocol ID
- STUDY147643
- Acronym
- KDHL
- Status last verified
- Nov 2023
- First submitted
- 10 Feb 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Investigation of the Ketogenic Diet's Health Effects Through Multi-Omics Assessment
- ClinicalTrials.gov ID
- NCT05939011
- Acronym / sponsor ID
- KDHL / STUDY147643
- Conditions
- Ketogenic Dieting, Ketoses, Metabolic, Ketosis
- Keywords
- ketogenic, well-formulated ketogenic diet, keto
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- University of California, Davis
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| Well-formulated ketogenic diet (WFKD) | Experimental | Behavioral: Well-formulated Ketogenic DietThe 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. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 30 to 55 years
- Speaks English as primary language
- BMI 20.0-34.9 kg/m^2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Well-formulated Ketogenic Diet1:1 ketogenic diet that is focused on intake of high-quality fats (nuts/seeds, fatty fish, avocado) and reduction in processed food. | Behavioural | Well-formulated ketogenic diet (WFKD) |
Primary outcome
Changes in Body Composition-- dual x-ray absorptiometry (DXA)
Time frame: Baseline, 8 Week
Measures of tissue distribution
Changes in Waist Circumference (WC)
Time frame: Baseline, 4 Week, 8 Week
Waist circumference (cm)
Changes in Body Mass Index (BMI)
Time frame: Baseline, 4 Week, 8 Week
Ratio of height and weight in kg/m^2
Changes in Homeostatic model assessment of Insulin Resistance (HOMA-IR)
Time frame: Baseline, 4 Week, 8 Week
Ratio of fasting glucose and fasting insulin with a conversion factor, unitless
Changes in Advanced Lipid Panel
Time frame: Baseline, 8 Week
Changes in Inflammation
Time frame: Baseline, 8 Week
Changes in high sensitivity C-reactive protein (hs-CRP) (mg/L)
2 secondary outcomes
Changes in transcriptomic sequencing pathways
Time frame: Baseline, 8 weeks
Gut microbial changes
Time frame: Baseline, 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra K Sullivan, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Well-formulated Ketogenic Diet in people with Ketogenic Dieting and Ketoses, Metabolic, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Body Composition-- dual x-ray absorptiometry (DXA) (time frame: Baseline, 8 Week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.