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

NCT ID: NCT05980858

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2024-04-11

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).

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.

Conditions

Ketosis; Ketonemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Beta-hydroxybutyrate

Intervention Type: DIETARY_SUPPLEMENT

Each subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.

Placebo

Intervention Type: OTHER

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

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).

Group Type: ACTIVE_COMPARATOR

Beta-hydroxybutyrate

Intervention Type: DIETARY_SUPPLEMENT

Each subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.

Placebo

Intervention Type: OTHER

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

Interventions

Beta-hydroxybutyrate

Each subject receive Beta-hydroxybutyrate 300mg/kg x 3 for five days. After the treatment period effect variables will be examined.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gødstrup Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesper N Bech, PhD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Clinic in Nephrology and Hypertension

Locations

The University Clinic of Nephrology and Hypertension

Herning, Jutland, Denmark

Countries

Denmark

Other Identifiers

TZL-2-2023

Identifier Type: -

Identifier Source: org_study_id