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

Ketosis Clinical Trial

— KETO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05980858
• Other study ID #: TZL-2-2023
• Status: Completed
• Phase: N/A
• Start date: August 10, 2023
• Est. completion date: April 11, 2024

Study information

• Verified date: May 2024
• Source: Gødstrup Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 11, 2024
• Est. primary completion date: April 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketonemia
• Ketosis

Intervention

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.

Locations

Country	Name	City	State
Denmark	The University Clinic of Nephrology and Hypertension	Herning	Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Gødstrup Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GFR	Change in GFR measured by Tc99m-DTPA clearance	Measured after each treatment period (day 6 and approximately day 26)
Primary	Renal Blood Flow (RBF)	Change in RBF determined by water based PET/CT scans	Subjects are scanned after each treatment period (day 6 and approximately day 26)
Secondary	24-hour blood pressure	Change in systolic 24-hour blood pressure	Measured after each treatment period (day 6 and approximately day 26)
Secondary	Vasoactive hormones	Change in plasma levels of angiotensin II, aldosterone, renin, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP), copeptin	Measured after each treatment period (day 6 and approximately day 26)
Secondary	Beta-hydroxybutyrate	Change ind p-beta-hydroxybutyrate	Measured after each treatment period (day 6 and approximately day 26)
Secondary	Renal tubular transport proteins	Urine excretions of aquaporin 2 (AQP2), thiazide-sensitive sodium-chloride cotransporter (NCC) and distal epithelial sodium channel (ENaC)	Measured after each treatment period (day 6 and approximately day 26)