NCT05917873

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Sep 2023

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

June 5, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2024

Completed
Last Updated

August 28, 2025

Status Verified

October 1, 2024

Enrollment Period

1.3 years

First QC Date

June 5, 2023

Last Update Submit

August 21, 2025

Conditions

Obesity

Keywords

Insulin sensitivityLipolysisAppetite

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity expressed as an M-value

    On all study days, a hyperinsulinemic-euglycemic clamp is used to determine insulin sensitivity: continuous infusion of insulin (1 milliunit · kg lean body mass-1 · min-1) for 2 hours. The blood glucose is clamped at 5 mmol/l.

    Throughout the cross-over design, approximately 12 weeks

Secondary Outcomes (33)

  • Differences in lipolysis rate

    Throughout the cross-over design, approximately 12 weeks

  • Differences in body weight and composition

    Throughout the cross-over design, approximately 12 weeks

  • Differences in gastric emptying rate

    Throughout the cross-over design, approximately 12 weeks

  • Cardiac Output (CO)

    Throughout the cross-over design, approximately 12 weeks

  • Left Ventricular Ejection Fraction (LVEF)

    Throughout the cross-over design, approximately 12 weeks

  • +28 more secondary outcomes

Study Arms (2)

LaKe arm

EXPERIMENTAL

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

Dietary Supplement: LaKe Ester

Placebo arm

PLACEBO COMPARATOR

Placebo treatment

Dietary Supplement: Placebo

Interventions

LaKe EsterDIETARY_SUPPLEMENT

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

LaKe arm
PlaceboDIETARY_SUPPLEMENT

Taste and appearance matched noncaloric placebo

Placebo arm

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Steno Diabetes Center Aarhus

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Niels Møller, Professor

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 5, 2023

First Posted

June 26, 2023

Study Start

September 7, 2023

Primary Completion

December 11, 2024

Study Completion

December 11, 2024

Last Updated

August 28, 2025

Record last verified: 2024-10

Locations

DK(1)