KetosisKETONCT05980858
Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
A study testing Beta-hydroxybutyrate in people with Ketosis and Ketonemia, run by Gødstrup Hospital at 1 site in Denmark.
Trial summary
This is a randomized, placebo-controlled, double-blinded crossover design. Fifteen healthy subjects 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 to 30 yearsHealthy volunteers can take part
- What is being tested?
- Beta-hydroxybutyrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Aug 2023to 11 Apr 2024
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < 30 kg/m2
- Safe contraception if women in childbearing age
- Normal biochemical screening
Who cannot join
- Pregnancy or breast feeding
- Major heart-, liver-, kidney-, lung-, neurological- or endocrine disease
- Daily use of prescription drugs (expect for contraceptives)
- Alcohol or drug abuse
- Periodic fasting
- Routinely intake of ketogenic diet
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The University Clinic of Nephrology and Hypertension
Herning, Jutland, 7400
About this study
This is a randomized, placebo-controlled, double-blinded crossover design. Fifteen healthy subjects 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 increases renal blood flow and glomerular filtration rate (GFR).
Methods: It is a randomized, placebo-controlled double-blinded cross over study. Fifteen healthy subjects 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.
- Being tested
- Beta-hydroxybutyrate, Placebo
- Keywords
- Kidney circulation, Kidney physiology, Kidney function, Glomerular Filtration Rate
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-hydroxybutyrateDietary supplement
Each subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.
PlaceboOther
Each subject 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 |
|---|---|---|
| KetoneAid KE4, then Placebo drink | Active comparator | For five days each subject will receive beta-hydroxybutyrate (KE4), then crossed over to receive placebo drink for 5 days. Receives: Dietary Supplement: Beta-hydroxybutyrate; Other: Placebo |
| Placebo drink, then KetoneAid KE4 | Active comparator | For five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate (KE4). Receives: Dietary Supplement: Beta-hydroxybutyrate; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
GFR
Change in GFR measured by Tc99m-DTPA clearance
Measured: Measured after each treatment period (day 6 and approximately day 26)
Renal Blood Flow (RBF)
Change in RBF determined by water based PET/CT scans
Measured: Subjects are scanned after each treatment period (day 6 and approximately day 26)
Secondary outcomes (4)
24-hour blood pressure
Change in systolic 24-hour blood pressure
Measured: Measured after each treatment period (day 6 and approximately day 26)
Vasoactive hormones
Change in plasma levels of angiotensin II, aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin
Measured: Measured after each treatment period (day 6 and approximately day 26)
Beta-hydroxybutyrate
Change ind p-beta-hydroxybutyrate
Measured: Measured after each treatment period (day 6 and approximately day 26)
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 (day 6 and approximately day 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start10 Aug 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gødstrup Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesper N Bech, PhD, Prof, Principal investigator, University Clinic in Nephrology and Hypertension
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980858
- Sponsor's protocol ID
- TZL-2-2023
- Acronym
- KETO
- Status last verified
- Nov 2024
- First submitted
- 5 Jul 2023
- Last updated
- 22 Nov 2024
- 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 22 Nov 2024. 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 Healthy Subjects
- ClinicalTrials.gov ID
- NCT05980858
- Acronym / sponsor ID
- KETO / TZL-2-2023
- Keywords
- Kidney circulation, Kidney physiology, Kidney function, Glomerular Filtration Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gødstrup HospitalUniversity, hospital or other
- Study start
- 10 Aug 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 8 Aug 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.
This is a randomized, placebo-controlled, double-blinded crossover design. Fifteen healthy subjects 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 increases renal blood flow and glomerular filtration rate (GFR).
Methods: It is a randomized, placebo-controlled double-blinded cross over study. Fifteen healthy subjects 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 |
|---|---|---|
| KetoneAid KE4, then Placebo drink | Active comparator | Dietary Supplement: Beta-hydroxybutyrate, Other: PlaceboFor five days each subject will receive beta-hydroxybutyrate (KE4), then crossed over to receive placebo drink for 5 days. |
| Placebo drink, then KetoneAid KE4 | Active comparator | Dietary Supplement: Beta-hydroxybutyrate, Other: PlaceboFor five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate (KE4). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI < 30 kg/m2
- Safe contraception if women in childbearing age
- Normal biochemical screening
Key exclusion criteria (6 listed)
- Pregnancy or breast feeding
- Major heart-, liver-, kidney-, lung-, neurological- or endocrine disease
- Daily use of prescription drugs (expect for contraceptives)
- Alcohol or drug abuse
- Periodic fasting
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 |
|---|---|---|
| Beta-hydroxybutyrateEach subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined. | Dietary supplement | KetoneAid KE4, then Placebo drink, Placebo drink, then KetoneAid KE4 |
| PlaceboEach subject receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined. | Other | KetoneAid KE4, then Placebo drink, Placebo drink, then KetoneAid KE4 |
Primary outcome
GFR
Time frame: Measured after each treatment period (day 6 and approximately day 26)
Change in GFR measured by Tc99m-DTPA clearance
Renal Blood Flow (RBF)
Time frame: Subjects are scanned after each treatment period (day 6 and approximately day 26)
Change in RBF determined by water based PET/CT scans
4 secondary outcomes
24-hour blood pressure
Time frame: Measured after each treatment period (day 6 and approximately day 26)
Vasoactive hormones
Time frame: Measured after each treatment period (day 6 and approximately day 26)
Beta-hydroxybutyrate
Time frame: Measured after each treatment period (day 6 and approximately day 26)
Renal tubular transport proteins
Time frame: Measured after each treatment period (day 6 and approximately day 26)
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 22 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Ketosis
RecruitingPhase 2/3
Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
Alcohol Use Disorder, Alcohol Withdrawal
Active, not recruiting
Effects of Short-term Adaptation to Ketogenic Diet on Endurance Trained Athletes
Ketogenic Diet, Control Condition
Recruiting
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
Healthy Volunteers and Diabetes Participants
Recruiting
LIfestyle MEtabotype Study B (LIME-B)
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.
Jesper N Bech, PhD, Prof principal investigator
University Clinic in Nephrology and Hypertension
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-hydroxybutyrate in people with Ketosis and Ketonemia, 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 3 inclusion and 6 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 22 Nov 2024. 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. 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?
GFR (time frame: Measured after each treatment period (day 6 and approximately day 26)). The study lists 2 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 22 Nov 2024.