Metabolic Effects of Four-week Lactate-ketone Ester Supplementation (MetaLaKe)

University of Aarhus

Status: Active, not recruiting

Conditions: Obesity

Treatments: Dietary Supplement: LaKe Ester; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05917873

98128

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

LaKe arm

Experimental group

Description:

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

Treatment:

Dietary Supplement: LaKe Ester

Placebo arm

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Dietary Supplement: Placebo