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

NCT06418074 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-10

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

Placebo

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

Sponsors & Collaborators

  • Gødstrup Hospital

    lead OTHER

Principal Investigators

  • Trine Z Lyksholm, MD · The University Clinic for Nephrology and Hypertenion, Regional Hospital Godstrup

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2025-06-19
Completion
2025-06-19

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06418074 on ClinicalTrials.gov