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Metabolic Effects of Four-week Lactate-ketone Ester Supplementation

NCT05917873 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-28

No results posted yet for this study

Summary

Recent research reveals intriguing results concerning the role of exogenous lactate and the ketone body 3-hydroxybutyrate (3-OHB) as therapeutic tools to combat obesity and related conditions. Thus, oral administration of lactate and 3-OHB have separately been shown to suppress appetite sensations and slow gastric emptying while administered orally. Both seem to inhibit lipolysis while oral 3-OHB administration have shown direct insulin sensitizing effects. Furthermore, both substrates can be used as fuel for the heart.

The goal of this placebo-controlled randomized crossover design is to test exogenous lactate and the ketone body 3-hydroxybutyrate (3-OHB) in healthy, non-diabetic, obese adults.

The main questions it aims to answer are if chronic administration of LaKe ester affect or improve the following endpoints:

* Insulin sensitivity
* Appetite sensations
* Gastric emptying
* Lipolysis
* Cardiac output
* Left Ventricular Ejection Fraction
* Global Longitudinal Strain and other echocardiographic measures listed below

Participants will ingest a combined lactate and ketone body ester (LaKe ester) or placebo twice a day for 28 days before experimental days.

Conditions

Interventions

DIETARY_SUPPLEMENT

LaKe Ester

Lactate and ketone body ester (one equivalent of S-lactate and one equivalent of 1,3-butanediol / D-β-hydroxybutyrate)

DIETARY_SUPPLEMENT

Placebo

Taste and appearance matched noncaloric placebo

Sponsors & Collaborators

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • Aarhus University Hospital

    collaborator OTHER

  • Riisfort

    collaborator UNKNOWN

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Niels Møller, Professor · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-07
Primary Completion
2024-12-11
Completion
2024-12-11

Countries

  • Denmark

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05917873 on ClinicalTrials.gov