Ketosis(KETO-HT)NCT06418074
Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity
A study testing Ketone Monoester (KE4) in people with Ketosis and Essential Hypertension, run by Gødstrup Hospital at 1 site in Denmark.
Trial summary
This is a randomized, placebo-controlled, double-blinded crossover design. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ketosis, Essential Hypertension
- What is being tested?
- Ketone Monoester (KE4)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Sep 2024to 19 Jun 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Essential hypertension (treatment with maximum 2 antihypertensive drugs)
- eGFR > 60ml/min
- BMI < 35 kg/m2
- Urine Albumin Creatinin Ratio (UACR) < 300mg/g
- Safe contraception if women in childbearing age
Who cannot join
- Diabetes type 1 or 2
- Heart Failure
- Pregnancy or breast feeding
- Liver disease
- Malignant disease
- Recent acute myocardial infarction (AMI), apoplexia/transient ischemic attack (TIA) (within 12 months of inclusion)
Show all 11Show fewer
- Daily use of prescription drugs (expect for contraceptives)
- Alcohol or drug abuse
- Periodic fasting
- Routinely intake of ketogenic diet
- Treatment with immunosuppressants or SGLT2-inhibitors
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital
Herning, 7400
About this study
Official title: Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Patients With Essential Hypertension
This is a randomized, placebo-controlled, double-blinded crossover design. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). After a washout period of 14 days, the subjects are crossed over to a similar treatment period with the other treatment. The study is terminated by measuring effect variables after the second treatment period (experiment day 2).
Read the detailed description
Background: Renewed interest in ketone bodies has emerged, partly driven by the recent success of selective sodium glucose co transporter 2 (SGLT-2) inhibition in preventing cardiovascular deaths in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). Effects of ketosis are of importance in order to understand the beneficial effects of SGLT-2 inhibitors and to account for the full therapeutic potential of this treatment.
Hypothesis: Ketosis decreases 24 hour systolic blood pressure and increases renal blood flow and glomerular filtration rate (GFR).
Methods: It is a randomized, placebo-controlled double-blinded cross over study. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or for 5 days. After a wash out period of at least 14 days, the subjects are crossed over to receive the other treatment. After each treatment period effect variables will be measured including Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT)
Perspectives: The study has the potential to provide information regarding the therapeutic potential of treatment with ketone bodies and understanding of conditions characterized by ketosis, such as SGLT2-inhibitor treatment.
- Conditions
- Ketosis, Essential Hypertension
- Being tested
- Ketone Monoester (KE4), Placebo
- Keywords
- Natriuresis, Kidney circulation, Kidney physiology, Glomerular Filtration Rate
- Medical subject headings
- Ketosis, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone Monoester (KE4)Dietary supplement
Each subject will receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4) 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.
PlaceboOther
Each subject will receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined.
| Study group | Role | What they receive |
|---|---|---|
| Ketone Monoester (KE4), then Placebo drink | Active comparator | For five days each subject will receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4), then crossed over to receive placebo drink for 5 days. Receives: Dietary Supplement: Ketone Monoester (KE4); Other: Placebo |
| Placebo drink, then Ketone Monoester (KE4) | Placebo comparator | For five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4). Receives: Dietary Supplement: Ketone Monoester (KE4); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour systolic blood pressure
Change in systolic 24-hour blood pressure
Measured: Measured after each treatment period (each treatment period is 6 days)
Secondary outcomes (5)
Renal Blood Flow (RBF)
Change in RBF determined by water based PET/CT scans
Measured: Measured after each treatment period (each treatment period is 6 days)
GFR
Change in GFR measured by Tc99m-DTPA clearance
Measured: Measured after each treatment period (each treatment period is 6 days)
Vasoactive hormones
Change in plasma levels of aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin
Measured: Measured after each treatment period (each treatment period is 6 days)
P-Beta-hydroxybutyrate
Change ind p-beta-hydroxybutyrate concentration
Measured: Measured after each treatment period (each treatment period is 6 days)
Plasma concentration of renal tubular transport proteins
Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC)
Measured: Measured after each treatment period (each treatment period is 6 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start11 Sep 2024
- Primary completion19 Jun 2025
- Study completion19 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetosisStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trine Z Lyksholm, MD, Principal investigator, The University Clinic for Nephrology and Hypertenion, Regional Hospital Godstrup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418074
- Sponsor's protocol ID
- TZL-1-2024
- Acronym
- (KETO-HT)
- Status last verified
- Dec 2025
- First submitted
- 6 May 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Patients With Essential Hypertension
- ClinicalTrials.gov ID
- NCT06418074
- Acronym / sponsor ID
- (KETO-HT) / TZL-1-2024
- Conditions
- Ketosis, Essential Hypertension
- Keywords
- Natriuresis, Kidney circulation, Kidney physiology, Glomerular Filtration Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 19 Jun 2025 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 16 May 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.
This is a randomized, placebo-controlled, double-blinded crossover design. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or placebo delivered by KetoneAid. After a period of 5-days treatment, effect variables will be measured (experiment day 1). After a washout period of 14 days, the subjects are crossed over to a similar treatment period with the other treatment. The study is terminated by measuring effect variables after the second treatment period (experiment day 2).
Detailed description
Background: Renewed interest in ketone bodies has emerged, partly driven by the recent success of selective sodium glucose co transporter 2 (SGLT-2) inhibition in preventing cardiovascular deaths in patients with diabetes mellitus (DM) and chronic kidney disease (CKD). Effects of ketosis are of importance in order to understand the beneficial effects of SGLT-2 inhibitors and to account for the full therapeutic potential of this treatment.
Hypothesis: Ketosis decreases 24 hour systolic blood pressure and increases renal blood flow and glomerular filtration rate (GFR).
Methods: It is a randomized, placebo-controlled double-blinded cross over study. Nineteen patients with essential hypertension will be randomized to receive either ketone bodies (KE4) or for 5 days. After a wash out period of at least 14 days, the subjects are crossed over to receive the other treatment. After each treatment period effect variables will be measured including Technetium(Tc)99m - Diethylenetriamine pentaacetate (DTPA) clearance and water based positron emission tomography computed tomography (PET/CT)
Perspectives: The study has the potential to provide information regarding the therapeutic potential of treatment with ketone bodies and understanding of conditions characterized by ketosis, such as SGLT2-inhibitor treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketone Monoester (KE4), then Placebo drink | Active comparator | Dietary Supplement: Ketone Monoester (KE4), Other: PlaceboFor five days each subject will receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4), then crossed over to receive placebo drink for 5 days. |
| Placebo drink, then Ketone Monoester (KE4) | Placebo comparator | Dietary Supplement: Ketone Monoester (KE4), Other: PlaceboFor five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Essential hypertension (treatment with maximum 2 antihypertensive drugs)
- eGFR > 60ml/min
- BMI < 35 kg/m2
- Urine Albumin Creatinin Ratio (UACR) < 300mg/g
- Safe contraception if women in childbearing age
Key exclusion criteria (11 listed)
- Diabetes type 1 or 2
- Heart Failure
- Pregnancy or breast feeding
- Liver disease
- Malignant disease
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 |
|---|---|---|
| Ketone Monoester (KE4)Each subject will receive beta-hydroxybutyrate boned to R 1,3 Butandiol (KE4) 300mg/kg x 3 for five days. After the treatment period effect variables will be examined. | Dietary supplement | Ketone Monoester (KE4), then Placebo drink, Placebo drink, then Ketone Monoester (KE4) |
| PlaceboEach subject will receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined. | Other | Ketone Monoester (KE4), then Placebo drink, Placebo drink, then Ketone Monoester (KE4) |
Primary outcome
24-hour systolic blood pressure
Time frame: Measured after each treatment period (each treatment period is 6 days)
Change in systolic 24-hour blood pressure
5 secondary outcomes
Renal Blood Flow (RBF)
Time frame: Measured after each treatment period (each treatment period is 6 days)
GFR
Time frame: Measured after each treatment period (each treatment period is 6 days)
Vasoactive hormones
Time frame: Measured after each treatment period (each treatment period is 6 days)
P-Beta-hydroxybutyrate
Time frame: Measured after each treatment period (each treatment period is 6 days)
Plasma concentration of renal tubular transport proteins
Time frame: Measured after each treatment period (each treatment period is 6 days)
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 10 Dec 2025.
- Individual participant dataSharing planned: No
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Effects of Short-term Adaptation to Ketogenic Diet on Endurance Trained Athletes
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Variations in Ketone Metabolism
Ketosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
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Recruiting
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Nutritional and Metabolic Diseases, Prediabetes
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.
Trine Z Lyksholm, MD principal investigator
The University Clinic for Nephrology and Hypertenion, Regional Hospital Godstrup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Monoester (KE4) in people with Ketosis and Essential Hypertension, run by Gødstrup Hospital at 1 site in Denmark.
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 5 inclusion and 11 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 10 Dec 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
24-hour systolic blood pressure (time frame: Measured after each treatment period (each treatment period is 6 days)). 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 10 Dec 2025.