Metabolic Effects of Four-week Lactate-ketone Ester Supplementation

Phase

N/A

Condition

Diabetes (Pediatric)

Hormone Deficiencies

Stress

Treatment

LaKe Ester

Placebo

Clinical Study ID

NCT05917873

98128

Ages 30-60
All Genders
Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

Medication that affect energy or glucose metabolism, eg metformin, insulin orGlucagon-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

Study Design