Metabolic Effects of Four-week Lactate-ketone Ester Supplementation

NCT ID: NCT05917873

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-07
• Study Completion Date: 2024-12-11

Brief 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

Obesity

Study Design

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

Study Groups

LaKe arm

Ingestion of a combined lactate and ketone body ester, 25 ml twice daily for 28 days.

Group Type: EXPERIMENTAL

LaKe Ester

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo arm

Placebo treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Taste and appearance matched noncaloric placebo

Interventions

LaKe Ester

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Taste and appearance matched noncaloric placebo

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Age between 30-60 years
• BMI range 30-40
• Glycated haemoglobin (HbA1c) < 48 mmol/mol
• Otherwise 'healthy'
• Written and oral consent

Exclusion Criteria

• Medication that affect energy or glucose metabolism, eg metformin, insulin or Glucagon-like peptide-1 receptor (GLP-1) agonists
• Specific diets (eg practicing ketogenic diets)
• Cardiac arrhythmias (eg atrial fibrillation)
• Ongoing acute/chronic serious diseases (eg, anemia, chronic kidney or liver disease)
• Inability to understand Danish or English

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Riisfort

UNKNOWN

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Niels Møller, Professor

Role: STUDY_DIRECTOR

Aarhus University Hospital

Locations

Steno Diabetes Center Aarhus

Aarhus, , Denmark

Countries

Denmark

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

98128

Identifier Type: -

Identifier Source: org_study_id