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| Name | Class |
|---|---|
| Novo Nordisk A/S | INDUSTRY |
| Aarhus University Hospital | OTHER |
| Riisfort | UNKNOWN |
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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:
Participants will ingest a combined lactate and ketone body ester (LaKe ester) or placebo twice a day for 28 days before experimental days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LaKe arm | Experimental | Ingestion of a combined lactate and ketone body ester, 25 ml twice daily for 28 days. |
|
| Placebo arm | Placebo Comparator | Placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LaKe Ester | Dietary Supplement | Lactate and ketone body ester (one equivalent of S-lactate and one equivalent of 1,3-butanediol / D-β-hydroxybutyrate) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in lipolysis rate | Measured as differences in palmitate flux | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Møller, Professor | Aarhus University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steno Diabetes Center Aarhus | Aarhus | 8200 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2025 | Aug 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Dietary Supplement | Taste and appearance matched noncaloric placebo |
|
| Throughout the cross-over design, approximately 12 weeks |
| Differences in gastric emptying rate | Evaluated by using the acetaminophen test | 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) | Throughout the cross-over design, approximately 12 weeks |
| Left Ventricular Ejection Fraction (LVEF) | Echocardiographic changes | Throughout the cross-over design, approximately 12 weeks |
| Tricuspid annular plane systolic excursion (TAPSE) | Echocardiographic changes | Throughout the cross-over design, approximately 12 weeks |
| Global Longitudinal Strain (GLS) | Echocardiographic changes | Throughout the cross-over design, approximately 12 weeks |
| Mitral inflow velocities (E and A) | Echocardiographic changes | Throughout the cross-over design, approximately 12 weeks |
| Mitral plane velocities in the lateral mitral annulus (e' and s') | Echocardiographic changes | Throughout the cross-over design, approximately 12 weeks |
| Global work index (GWI) | Echocardiographic changes | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of 3-OHB | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of lactate | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of free fatty acids | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of glucose | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of insulin | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in plasma concentrations of growth/differentiation factor 15 (GDF-15) | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of gastric inhibitory polypeptide (GIP) | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of ghrelin | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of glucagon | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of liver-expressed antimicrobial peptide 2 (LEAP-2) | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of C-peptide | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of triglycerides | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of cholesterol | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of brain-derived neurotrophic factor (BDNF) | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of N-lactoyl-phenylalanine (Lac-Phe) | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Fibrosis-4 (FIB-4) | Blood sampling of alanine aminotransferase (ALAT), aspartate transaminase (ASAT), and thrombocytes | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of erythrocyte volume fraction (EVF) | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of Erythropoietin (EPO) | Blood sampling | Throughout the cross-over design, approximately 12 weeks |
| Changes in blood concentrations of inflammation markers | Blood sampling of C reactive protein (CRP) and leucocytes | 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). | 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). | 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). | 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). | Throughout the cross-over design, approximately 12 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |