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Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects (KETO)

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ClinicalTrials.gov Identifier: NCT05980858
Recruitment Status : Completed
First Posted : August 8, 2023
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
Trine Lyksholm, Gødstrup Hospital

Study Description
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Brief 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). 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).

Condition or disease Intervention/treatment Phase
Ketosis Ketonemia Dietary Supplement: Beta-hydroxybutyrate Other: Placebo Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Exogenous Ketosis on Renal Function, Renal Perfusion, and Sodium Excretory Capacity in Healthy Subjects
Actual Study Start Date : August 10, 2023
Actual Primary Completion Date : April 11, 2024
Actual Study Completion Date : April 11, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: KetoneAid KE4, then Placebo drink
For five days each subject will receive beta-hydroxybutyrate (KE4), then crossed over to receive placebo drink for 5 days.
 Dietary Supplement: Beta-hydroxybutyrate
Each subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.

Other: Placebo
Each subject receive a placebo drink 3 x day for five days. After the treatment period effect variables will be examined.
Active Comparator: Placebo drink, then KetoneAid KE4
For five days each subject will receive a placebo drink three times daily, then subjects are crossed over to receive beta-hydroxybutyrate (KE4).
 Dietary Supplement: Beta-hydroxybutyrate
Each subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.

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


Outcome Measures
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Primary Outcome Measures :
  1. GFR [ Time Frame: Measured after each treatment period (day 6 and approximately day 26) ]
    Change in GFR measured by Tc99m-DTPA clearance

  2. 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


Secondary Outcome Measures :
  1. 24-hour blood pressure [ Time Frame: Measured after each treatment period (day 6 and approximately day 26) ]
    Change in systolic 24-hour blood pressure

  2. Vasoactive hormones [ Time Frame: Measured after each treatment period (day 6 and approximately day 26) ]
    Change in plasma levels of angiotensin II, aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin

  3. Beta-hydroxybutyrate [ Time Frame: Measured after each treatment period (day 6 and approximately day 26) ]
    Change ind p-beta-hydroxybutyrate

  4. Renal tubular transport proteins [ Time Frame: Measured after each treatment period (day 6 and approximately day 26) ]
    Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI < 30 kg/m2
  • Safe contraception if women in childbearing age
  • Normal biochemical screening

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05980858


Locations
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Denmark
The University Clinic of Nephrology and Hypertension
Herning, Jutland, Denmark, 7400
Sponsors and Collaborators
Gødstrup Hospital
Investigators
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Principal Investigator: Jesper N Bech, PhD, Prof University Clinic in Nephrology and Hypertension
More Information
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Responsible Party: Trine Lyksholm, Principal investigator, Gødstrup Hospital
ClinicalTrials.gov Identifier: NCT05980858    
Other Study ID Numbers: TZL-2-2023
First Posted: August 8, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Trine Lyksholm, Gødstrup Hospital:
Kidney circulation
Kidney physiology
Kidney function
Glomerular Filtration Rate
Additional relevant MeSH terms:
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Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases