Cardiovascular DiseasesNCT06515912
Ketogenic Diet in Healthy Adults With Differing BMI
A study testing Ketogenic Diet in people with Cardiovascular Diseases, run by Penn State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. Read more about this study
- Who is it for?
- Ages 25 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Ketogenic Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 31 Mar 2026
- 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 25 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 25-45 years
- Fasting direct LDL-C ≤100 mg/dL
- BMI of 18.5-22 kg/m2 or 30-35 kg/m2
- Blood pressure <140/90 mmHg
- Fasting blood glucose <126 mg/dL
- Fasting triglycerides <350 mg/dL
- ≤10% change in body weight for 6 months prior to enrollment
Who cannot join
- Have type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
- Prescription of anti-hypertensive, lipid-lowering or glucose-lowering drugs
- Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
- Diagnosed liver, kidney, or autoimmune disease
- Prior cardiovascular event (e.g., stroke, heart attack)
- Current pregnancy or intention of pregnancy within the next 2 months
Show all 24Show fewer
- Lactation within prior 6 months
- Follows a vegetarian or vegan diet
- Food allergies/intolerance/sensitives/dislikes of foods included in the study menu
- Antibiotic use within the prior 1 month
- Oral steroid use within the prior 1 month
- Use of tobacco or nicotine containing products within the past 6 months
- Cancer at any site within the past 10 years (eligible if ≥10 years without recurrence) or non-melanoma skin cancer with in the past 5 years (eligible if ≥5 years without recurrence)
- Participation in another clinical trial within 30 days of baseline
- Currently following a restricted or weight loss diet
- Previously consumed the ketogenic diet for more than 1 week
- Prior bariatric surgery
- Intake of >14 alcoholic drinks/week and/or lack of willingness to consume no alcohol while enrolled in the study and/or not willing to avoid alcohol consumption for 48 hours prior to test visits
- Current or past eating disorder
- Principal Investigator discretion related to the potential participant's ability to adhere to the study requirements including being able to come to the metabolic kitchen to pick-up food five days per week
- Planning to relocate out of the State College area in the next 2 months
- Unwilling to refrain from plasma/blood donations during the study
- Previously diagnosed familial hypercholesterolemia
- If a potential participant takes thyroid medicine, abnormal thyroid stimulating hormone (TSH) concentration (TSH outside of normal range of 0.5 - 4.5 mIU/L)
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State University
University Park, Pennsylvania, 16802
About this study
Official title: The Ketogenic Diet, Blood Lipids, and Heart Health in Healthy Adults With Differing BMI
The goal of this clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are:
- Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity?
- Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity?
Read more
Participants will:
- Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period
- Visit the metabolic kitchen daily (Monday-Friday) to pick up meals
- Attend 5 fasting visits at the Clinical Research Center for testing
Read the detailed description
This is a controlled feeding study investigating if four weeks on the ketogenic diet will cause differential alterations in blood lipids and lipoproteins, vascular health as measured by fasting flow mediated dilation (FMD), and mechanistic markers of lipid metabolism in adults with normal weight when compared to adults with obesity. Outcomes will be measured at both the beginning and end of the study on two consecutive days, for a total of four clinic appointments.
- Conditions
- Cardiovascular Diseases
- Being tested
- Ketogenic Diet
- Keywords
- Ketogenic Diet
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic DietOther
A ketogenic diet with 5% carbohydrate, 18% protein, and 77% fat by percent kcal.
| Study group | Role | What they receive |
|---|---|---|
| Low BMI | Experimental | BMI 18.5 - 22 kg/m^2 Intervention: Ketogenic diet 28 days Receives: Other: Ketogenic Diet |
| High BMI | Active comparator | BMI 30-35 kg/m^2 Intervention: Ketogenic diet 28 days Receives: Other: Ketogenic Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-cholesterol concentration change from baseline
Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. Change in LDL-cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Secondary outcomes (23)
Endothelial function - Flow Mediated Dilation (FMD) change from baseline
Assessed by fasting brachial arterial ultrasound after transient ischemia expressed in percentage (%). Change in FMD will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Triglycerides concentration change from baseline
Assessed from fasting blood draw expressed in mg/dL. Change in triglycerides will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Total cholesterol concentration change from baseline
Assessed from fasting blood draw expressed in mg/dL. Change in total cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
HDL-cholesterol concentration change from baseline
Assessed from fasting blood draw expressed in mg/dL. Change in HDL-cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Concentration of LDL and triglyceride-rich lipoprotein subparticles change from baseline
Measured via Nuclear Magnetic Resonance and expressed in nmol/L. Change in concentration will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Concentration of HDL subparticles change from baseline
Measured via Nuclear Magnetic Resonance and expressed in µmol/L. Change in concentration will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Size of LDL, HDL, and triglyceride-rich lipoprotein particles change from baseline
Measured via Nuclear Magnetic Resonance and expressed in nm. Change in size will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Central systolic and diastolic blood pressure change from baseline
Assessed using a SphymoCor Xcel (Atcor Medical) and expressed in mmHg. Change in blood pressures will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Brachial systolic and diastolic blood pressure change from baseline
Assessed using a SphymoCor Xcel (Atcor Medical) and expressed in mmHg. Change in blood pressures will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Carotid-femoral pulse wave velocity change from baseline
A measure of arterial stiffness - assessed using a SphymoCor Xcel (Atcor Medical) and expressed in meters/second. Change in pulse wave velocity will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Serum Insulin concentration change from baseline
Assessed in a fasting blood draw and expressed in micro IU/mL. Change in insulin will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Plasma glucose concentration change from baseline
Assessed in a fasting blood draw and expressed in mg/dL. Change in glucose will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Homeostatic model assessment for insulin resistance (HOMA-IR) change from baseline
Calculated from insulin and glucose measured from a fasting blood sample. Calculated as (insulin × glucose) / 22.5. Change in HOMA-IR will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Cholesteryl ester transfer protein (CETP) activity change from baseline
Assessed in fasting plasma samples using an enzymatic activity kit. Change in CETP activity will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Lipoprotein lipase (LPL) activity change from baseline
Assessed in fasting plasma samples using an enzymatic activity kit. Change in LPL activity will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Angiopoietin-Like Protein 3 (ANGPTL3) concentration change from baseline
Assessed in fasting plasma samples using an ELISA kit and expressed in ng/mL. Change in ANGPTL3 concentration will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Angiopoietin-Like Protein 4 (ANGPTL4) concentration change from baseline
Assessed in fasting plasma samples using an ELISA kit and expressed in ng/mL. Change in ANGPTL4 concentration will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Angiopoietin-Like Protein 8 (ANGPTL8) concentration change from baseline
Assessed in fasting plasma samples using an ELISA kit and expressed in pg/mL. Change in ANGPTL8 concentration will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Glucagon concentration change from baseline
Assessed from fasting blood draw expressed in pg/mL. Change in glucagon concentration will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Total adiposity change from baseline
Assessed from Dual-energy X-ray absorptiometry as % body mass. Change in total adiposity will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Estimated visceral adipose tissue change from baseline
Assessed from Dual-energy X-ray absorptiometry and calculated by software in grams (g). Change in estimated visceral adipose tissue will be calculated as the end of diet measure minus the baseline measure.
Measured: 4 weeks
Alanine transaminase (ALT) change from baseline
Assessed from fasting blood draw expressed in U/L. Change in ALT concentration will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Aspartate transaminase (AST) change from baseline
Assessed from fasting blood draw expressed in U/L. Change in AST concentration will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start29 Jan 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Petersen PhD, APD, FAHA, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515912
- Sponsor's protocol ID
- KTO
- Status last verified
- Apr 2026
- First submitted
- 15 Jul 2024
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ketogenic Diet, Blood Lipids, and Heart Health in Healthy Adults With Differing BMI
- ClinicalTrials.gov ID
- NCT06515912
- Acronym / sponsor ID
- KTO
- Conditions
- Cardiovascular Diseases
- Keywords
- Ketogenic Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 23 Jul 2024 (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 clinical trial is to examine the effect of the ketogenic diet over four weeks on blood lipid levels and risk factors for heart disease in adults with a healthy BMI compared to adults with a body mass index (BMI) in the range for obesity. The main questions it aims to answer are:
- Does the ketogenic diet cause larger increases in "bad cholesterol" (low density lipoprotein-cholesterol) in adults with a healthy BMI compared to adults with BMI in the range for obesity?
- Does the ketogenic diet cause larger decreases in vascular health in adults with a healthy BMI compared to adults with BMI in the range for obesity?
Participants will:
- Consume all of the study food provided and avoid intake of non-study foods during the 28-day diet period
- Visit the metabolic kitchen daily (Monday-Friday) to pick up meals
- Attend 5 fasting visits at the Clinical Research Center for testing
Detailed description
This is a controlled feeding study investigating if four weeks on the ketogenic diet will cause differential alterations in blood lipids and lipoproteins, vascular health as measured by fasting flow mediated dilation (FMD), and mechanistic markers of lipid metabolism in adults with normal weight when compared to adults with obesity. Outcomes will be measured at both the beginning and end of the study on two consecutive days, for a total of four clinic appointments.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low BMI | Experimental | Other: Ketogenic DietBMI 18.5 - 22 kg/m^2 Intervention: Ketogenic diet 28 days |
| High BMI | Active comparator | Other: Ketogenic DietBMI 30-35 kg/m^2 Intervention: Ketogenic diet 28 days |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 25-45 years
- Fasting direct LDL-C ≤100 mg/dL
- BMI of 18.5-22 kg/m2 or 30-35 kg/m2
- Blood pressure <140/90 mmHg
- Fasting blood glucose <126 mg/dL
Key exclusion criteria (24 listed)
- Have type 1 or type 2 diabetes or fasting blood glucose ≥126 mg/dL
- Prescription of anti-hypertensive, lipid-lowering or glucose-lowering drugs
- Intake of supplements that affect the outcomes of interest and unwilling to cease during the study period
- Diagnosed liver, kidney, or autoimmune disease
- Prior cardiovascular event (e.g., stroke, heart attack)
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 |
|---|---|---|
| Ketogenic DietA ketogenic diet with 5% carbohydrate, 18% protein, and 77% fat by percent kcal. | Other | High BMI, Low BMI |
Primary outcome
LDL-cholesterol concentration change from baseline
Time frame: 4 weeks
Assessed from fasting blood draw expressed in mg/dL. LDL-cholesterol will be measured directly via enzymatic assay. Change in LDL-cholesterol will be calculated as the mean of the end of diet measures (i.e., mean of day 29 and day 30 values) minus the mean of the baseline measures (i.e., mean of day 1 and day 2 values).
23 secondary outcomes
Endothelial function - Flow Mediated Dilation (FMD) change from baseline
Time frame: 4 weeks
Triglycerides concentration change from baseline
Time frame: 4 weeks
Total cholesterol concentration change from baseline
Time frame: 4 weeks
HDL-cholesterol concentration change from baseline
Time frame: 4 weeks
Concentration of LDL and triglyceride-rich lipoprotein subparticles change from baseline
Time frame: 4 weeks
Concentration of HDL subparticles change from baseline
Time frame: 4 weeks
Size of LDL, HDL, and triglyceride-rich lipoprotein particles change from baseline
Time frame: 4 weeks
Central systolic and diastolic blood pressure change from baseline
Time frame: 4 weeks
Brachial systolic and diastolic blood pressure change from baseline
Time frame: 4 weeks
Carotid-femoral pulse wave velocity change from baseline
Time frame: 4 weeks
Serum Insulin concentration change from baseline
Time frame: 4 weeks
Plasma glucose concentration change from baseline
Time frame: 4 weeks
Homeostatic model assessment for insulin resistance (HOMA-IR) change from baseline
Time frame: 4 weeks
Cholesteryl ester transfer protein (CETP) activity change from baseline
Time frame: 4 weeks
Lipoprotein lipase (LPL) activity change from baseline
Time frame: 4 weeks
Angiopoietin-Like Protein 3 (ANGPTL3) concentration change from baseline
Time frame: 4 weeks
Angiopoietin-Like Protein 4 (ANGPTL4) concentration change from baseline
Time frame: 4 weeks
Angiopoietin-Like Protein 8 (ANGPTL8) concentration change from baseline
Time frame: 4 weeks
Glucagon concentration change from baseline
Time frame: 4 weeks
Total adiposity change from baseline
Time frame: 4 weeks
Estimated visceral adipose tissue change from baseline
Time frame: 4 weeks
Alanine transaminase (ALT) change from baseline
Time frame: 4 weeks
Aspartate transaminase (AST) change from baseline
Time frame: 4 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 15 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be deposited into an open access repository once results from all pre-specified primary and secondary outcomes are published.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic Diet in people with Cardiovascular Diseases, run by Penn State University 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 7 inclusion and 24 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 15 Apr 2026. 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?
LDL-cholesterol concentration change from baseline (time frame: 4 weeks). 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 15 Apr 2026.