ObesityMetaLaKeNCT05917873
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
A study testing LaKe Ester in people with Obesity, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- LaKe Ester
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Sep 2023to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 30-60 years
- BMI range 30-40
- Glycated haemoglobin (HbA1c) < 48 mmol/mol
- Otherwise 'healthy'
- Written and oral consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- LaKe Ester, Placebo
- Keywords
- Insulin sensitivity, Lipolysis, Appetite
- Medical subject headings
- Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaKe EsterDietary supplement
Lactate and ketone body ester (one equivalent of S-lactate and one equivalent of 1,3-butanediol / D-β-hydroxybutyrate)
PlaceboDietary supplement
Taste and appearance matched noncaloric placebo
| Study group | Role | What they receive |
|---|---|---|
| LaKe arm | Experimental | Ingestion of a combined lactate and ketone body ester, 25 ml twice daily for 28 days. Receives: Dietary Supplement: LaKe Ester |
| Placebo arm | Placebo comparator | Placebo treatment Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Throughout the cross-over design, approximately 12 weeks
Secondary outcomes (33)
Differences in lipolysis rate
Measured as differences in palmitate flux
Measured: Throughout the cross-over design, approximately 12 weeks
Differences in body weight and composition
Dual-energy X-ray absorptiometry (DEXA) scan to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)
Measured: Throughout the cross-over design, approximately 12 weeks
Differences in gastric emptying rate
Evaluated by using the acetaminophen test
Measured: Throughout the cross-over design, approximately 12 weeks
Cardiac Output (CO)
Echocardiographic changes in left ventricular outflow tract (LVOT), velocity time integral (VTI) and heart rate (HR)
Measured: Throughout the cross-over design, approximately 12 weeks
Left Ventricular Ejection Fraction (LVEF)
Echocardiographic changes
Measured: Throughout the cross-over design, approximately 12 weeks
Tricuspid annular plane systolic excursion (TAPSE)
Echocardiographic changes
Measured: Throughout the cross-over design, approximately 12 weeks
Global Longitudinal Strain (GLS)
Echocardiographic changes
Measured: Throughout the cross-over design, approximately 12 weeks
Mitral inflow velocities (E and A)
Echocardiographic changes
Measured: Throughout the cross-over design, approximately 12 weeks
Mitral plane velocities in the lateral mitral annulus (e' and s')
Echocardiographic changes
Measured: Throughout the cross-over design, approximately 12 weeks
Global work index (GWI)
Echocardiographic changes
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of 3-OHB
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of lactate
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of free fatty acids
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of glucose
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of insulin
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in plasma concentrations of growth/differentiation factor 15 (GDF-15)
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of gastric inhibitory polypeptide (GIP)
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of ghrelin
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of glucagon
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of liver-expressed antimicrobial peptide 2 (LEAP-2)
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of C-peptide
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of triglycerides
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of cholesterol
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of brain-derived neurotrophic factor (BDNF)
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of N-lactoyl-phenylalanine (Lac-Phe)
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Fibrosis-4 (FIB-4)
Blood sampling of alanine aminotransferase (ALAT), aspartate transaminase (ASAT), and thrombocytes
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of erythrocyte volume fraction (EVF)
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of Erythropoietin (EPO)
Blood sampling
Measured: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of inflammation markers
Blood sampling of C reactive protein (CRP) and leucocytes
Measured: Throughout the cross-over design, approximately 12 weeks
Mood, assessed by Major Depression Inventory score (MDI)
Change in MDI score measured by Major Depression Inventory. The theoretical sum score ranges from 0 (no depression) to 50 (maximum depression).
Measured: Throughout the cross-over design, approximately 12 weeks
Anxiety Symptom Scale questionnaire (ASS)
Change in the Anxiety Symptom Scale questionnaire to screen for anxiety disorders. The theoretical sum score ranges from 0 (no anxiety) to 60 (maximum anxiety).
Measured: Throughout the cross-over design, approximately 12 weeks
Supplement tolerability
Assessed using a symptom questionnaire covering every organ system, including GI symptoms measured through the validated "Beverage Tolerability Questionnaire". Participants will rate the frequency of each item on a scale from 0 (no symptoms) to 5 (severe symptoms).
Measured: Throughout the cross-over design, approximately 12 weeks
Control of Eating Questionnaire (CoEQ)
The CoEQ has been used in clinical trials as a multi-dimensional measure of appetite, craving and mood regulation. Based on the previous 7 days, subjects will be asked to answer 21 questions (20 rated on a 100 mm visual analogue scale and one open-ended).
Measured: Throughout the cross-over design, approximately 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start7 Sep 2023
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Aarhus University Hospital, Riisfort
- Responsible party
- Sponsor
- Investigators
- Niels Møller, Professor, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917873
- Sponsor's protocol ID
- 98128
- Acronym
- MetaLaKe
- Status last verified
- Oct 2024
- First submitted
- 5 Jun 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
- ClinicalTrials.gov ID
- NCT05917873
- Acronym / sponsor ID
- MetaLaKe / 98128
- Conditions
- Obesity
- Keywords
- Insulin sensitivity, Lipolysis, Appetite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Aarhus University Hospital, Riisfort
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LaKe arm | Experimental | Dietary Supplement: LaKe EsterIngestion of a combined lactate and ketone body ester, 25 ml twice daily for 28 days. |
| Placebo arm | Placebo comparator | Dietary Supplement: PlaceboPlacebo treatment |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 30-60 years
- BMI range 30-40
- Glycated haemoglobin (HbA1c) < 48 mmol/mol
- Otherwise 'healthy'
- Written and oral consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaKe EsterLactate and ketone body ester (one equivalent of S-lactate and one equivalent of 1,3-butanediol / D-β-hydroxybutyrate) | Dietary supplement | LaKe arm |
| PlaceboTaste and appearance matched noncaloric placebo | Dietary supplement | Placebo arm |
Primary outcome
Insulin sensitivity expressed as an M-value
Time frame: Throughout the cross-over design, approximately 12 weeks
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.
33 secondary outcomes
Differences in lipolysis rate
Time frame: Throughout the cross-over design, approximately 12 weeks
Differences in body weight and composition
Time frame: Throughout the cross-over design, approximately 12 weeks
Differences in gastric emptying rate
Time frame: Throughout the cross-over design, approximately 12 weeks
Cardiac Output (CO)
Time frame: Throughout the cross-over design, approximately 12 weeks
Left Ventricular Ejection Fraction (LVEF)
Time frame: Throughout the cross-over design, approximately 12 weeks
Tricuspid annular plane systolic excursion (TAPSE)
Time frame: Throughout the cross-over design, approximately 12 weeks
Global Longitudinal Strain (GLS)
Time frame: Throughout the cross-over design, approximately 12 weeks
Mitral inflow velocities (E and A)
Time frame: Throughout the cross-over design, approximately 12 weeks
Mitral plane velocities in the lateral mitral annulus (e' and s')
Time frame: Throughout the cross-over design, approximately 12 weeks
Global work index (GWI)
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of 3-OHB
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of lactate
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of free fatty acids
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of glucose
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of insulin
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in plasma concentrations of growth/differentiation factor 15 (GDF-15)
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of gastric inhibitory polypeptide (GIP)
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of ghrelin
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of glucagon
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of liver-expressed antimicrobial peptide 2 (LEAP-2)
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of C-peptide
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of triglycerides
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of cholesterol
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of brain-derived neurotrophic factor (BDNF)
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of N-lactoyl-phenylalanine (Lac-Phe)
Time frame: Throughout the cross-over design, approximately 12 weeks
Fibrosis-4 (FIB-4)
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of erythrocyte volume fraction (EVF)
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of Erythropoietin (EPO)
Time frame: Throughout the cross-over design, approximately 12 weeks
Changes in blood concentrations of inflammation markers
Time frame: Throughout the cross-over design, approximately 12 weeks
Mood, assessed by Major Depression Inventory score (MDI)
Time frame: Throughout the cross-over design, approximately 12 weeks
Anxiety Symptom Scale questionnaire (ASS)
Time frame: Throughout the cross-over design, approximately 12 weeks
Supplement tolerability
Time frame: Throughout the cross-over design, approximately 12 weeks
Control of Eating Questionnaire (CoEQ)
Time frame: Throughout the cross-over design, approximately 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Møller, Professor study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LaKe Ester in people with Obesity, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity expressed as an M-value (time frame: Throughout the cross-over design, approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.