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

NCT06418074 | Completed

• 1 other identifier: TZL-1-2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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). 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).

Conditions

Ketosis; Essential Hypertension

Keywords

Natriuresis; Kidney circulation; Kidney physiology; Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

• 24-hour systolic blood pressure

  Change in systolic 24-hour blood pressure

  Measured after each treatment period (each treatment period is 6 days)

Secondary Outcomes (5)

• Renal Blood Flow (RBF)

  Measured after each treatment period (each treatment period is 6 days)

• GFR

  Measured after each treatment period (each treatment period is 6 days)

• Vasoactive hormones

  Measured after each treatment period (each treatment period is 6 days)

• P-Beta-hydroxybutyrate

  Measured after each treatment period (each treatment period is 6 days)

• Plasma concentration of renal tubular transport proteins

  Measured after each treatment period (each treatment period is 6 days)

Study Arms (2)

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.

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).

Dietary Supplement: Ketone Monoester (KE4); Other: Placebo

Interventions

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.

Ketone Monoester (KE4), then Placebo drink; Placebo drink, then Ketone Monoester (KE4)

Placebo OTHER

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

Ketone Monoester (KE4), then Placebo drink; Placebo drink, then Ketone Monoester (KE4)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diabetes type 1 or 2
• Heart Failure
• Pregnancy or breast feeding
• Liver disease
• Malignant disease
• 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

Sponsors & Collaborators

• Gødstrup Hospital: lead

Study Sites (1)

The University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital

Herning, 7400, Denmark

Location

MeSH Terms

Conditions

Ketosis; Essential Hypertension

Condition Hierarchy (Ancestors)

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

Study Officials

• Trine Z Lyksholm, MD

  The University Clinic for Nephrology and Hypertenion, Regional Hospital Godstrup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 16, 2024
• Study Start: September 11, 2024
• Primary Completion: June 19, 2025
• Study Completion: June 19, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)