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NCT Number: NCT06418074

Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity

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).

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Key information

Conditions

Ketosis Acid-Base Imbalance Acidosis Cardiovascular Diseases Essential Hypertension Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital

Herning, 7400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

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.

Placebo

Other

Each subject will receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined.

Primary outcomes

  1. 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

Secondary outcomes

  1. Renal Blood Flow (RBF)

    Time frame: Measured after each treatment period (each treatment period is 6 days)

    Change in RBF determined by water based PET/CT scans

  2. GFR

    Time frame: Measured after each treatment period (each treatment period is 6 days)

    Change in GFR measured by Tc99m-DTPA clearance

  3. Vasoactive hormones

    Time frame: Measured after each treatment period (each treatment period is 6 days)

    Change in plasma levels of aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin

  4. P-Beta-hydroxybutyrate

    Time frame: Measured after each treatment period (each treatment period is 6 days)

    Change ind p-beta-hydroxybutyrate concentration

  5. Plasma concentration of renal tubular transport proteins

    Time frame: Measured after each treatment period (each treatment period is 6 days)

    Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC)

Sponsors and collaborators

Lead sponsor

Gødstrup Hospital

Other

Registry information

Official study title

Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Patients With Essential Hypertension

Acronym: (KETO-HT)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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