---
title: Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity
nct_id: NCT06418074
overall_status: COMPLETED
phase: NA
sponsor: Gødstrup Hospital
study_type: INTERVENTIONAL
primary_condition: Ketosis
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06418074.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06418074"
ct_last_update_post_date: 2025-12-10
last_seen_at: "2026-05-12T06:52:53.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity

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

**NCT ID:** [NCT06418074](https://clinicaltrials.gov/study/NCT06418074)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** Gødstrup Hospital
- **Conditions:** Ketosis, Essential Hypertension
- **Start Date:** 2024-09-11
- **Completion Date:** 2025-06-19
- **CT.gov Last Update:** 2025-12-10

## 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).

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.
- **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).

## 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.
- **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

- **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

- **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))_

## Locations (1)

- The University Clinic in Nephrology and Hypertension, Gødstrup Region Hospital, Herning, Denmark

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.the university clinic in nephrology and hypertension, gødstrup region hospital|herning||denmark` — added _(2026-05-12)_

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*Canonical: https://parkinsonspathways.com/agent/trials/NCT06418074.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06418074*  
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