NCT05980858

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 8, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

August 10, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2024

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

July 5, 2023

Last Update Submit

November 20, 2024

Conditions

KetosisKetonemia

Keywords

Kidney circulationKidney physiologyKidney functionGlomerular Filtration Rate

Outcome Measures

Primary Outcomes (2)

  • GFR

    Change in GFR measured by Tc99m-DTPA clearance

    Measured after each treatment period (day 6 and approximately day 26)

  • 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 Outcomes (4)

  • 24-hour blood pressure

    Measured after each treatment period (day 6 and approximately day 26)

  • Vasoactive hormones

    Measured after each treatment period (day 6 and approximately day 26)

  • Beta-hydroxybutyrate

    Measured after each treatment period (day 6 and approximately day 26)

  • Renal tubular transport proteins

    Measured after each treatment period (day 6 and approximately day 26)

Study Arms (2)

KetoneAid KE4, then Placebo drink

ACTIVE COMPARATOR

For five days each subject will receive beta-hydroxybutyrate (KE4), then crossed over to receive placebo drink for 5 days.

Dietary Supplement: Beta-hydroxybutyrateOther: Placebo

Placebo drink, then KetoneAid KE4

ACTIVE COMPARATOR

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-hydroxybutyrateOther: Placebo

Interventions

Beta-hydroxybutyrateDIETARY_SUPPLEMENT

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

KetoneAid KE4, then Placebo drinkPlacebo drink, then KetoneAid KE4
PlaceboOTHER

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

KetoneAid KE4, then Placebo drinkPlacebo drink, then KetoneAid KE4

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University Clinic of Nephrology and Hypertension

Herning, Jutland, 7400, Denmark

Location

MeSH Terms

Conditions

Ketosis

Interventions

3-Hydroxybutyric Acid

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

HydroxybutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsKetone BodiesKetonesFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Jesper N Bech, PhD, Prof

    University Clinic in Nephrology and Hypertension

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2023

First Posted

August 8, 2023

Study Start

August 10, 2023

Primary Completion

April 11, 2024

Study Completion

April 11, 2024

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)