Keto Drinks as a Meal Primer in Patients With Type 2 Diabetes

University of Aarhus

Status: Completed

Conditions: Ketoses, Metabolic; Type 2 Diabetes

Treatments: Dietary Supplement: 3-hydroxybutyrate

Study type: Interventional

Funder types: Other

Identifiers

NCT05263401

1-10-72-282-20

Details and patient eligibility

About

The main objective of this clinical trial is to study the effects of orally administered ketone drinks containing the ketone body, 3-hydroxybutyrate (3-OHB), just before a meal in patients with type 2 diabetes. Moreover the investigators will compare the effects of two different ketone drinks.

The hypothesis is:

3-OHB as a pre-meal may:

• Lower postprandial blood glucose and lipids.
• Mediate release of intestinal hormones and affect gastric emptying.
• Affect appetite and other subjective measures related to food intake.

The effects of 3-OHB as a pre-meal will be investigated by blood samples, isotopic tracers examinations, paracetamol test, questionnaires and meal test.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes diagnosis, metformin treated or dietary treated
• HbA1C < 80 mmol/mol
• 25 < BMI < 35
• Written consent

Exclusion criteria

• Severe comorbidity
• Treatment with insulin, GLP-1 analogues, SGLT-2-inhibitors or sulfonylureas
• Specific diets, e.g. ketogenic diet
• PI finds the patient not fit (e.g. mental illness, too nervous, unacceptable screening blood tests or other)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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14 participants in 3 patient groups, including a placebo group

Ketone salt

Experimental group

Description:

Na-D/L-3-hydroxybutyrate dissolved in tap water.

Treatment:

Dietary Supplement: 3-hydroxybutyrate

Ketone ester

Experimental group

Description:

(R)-3-Hydroxybutyl (R)-3-hydroxybutyrate

Treatment:

Dietary Supplement: 3-hydroxybutyrate

Placebo

Placebo Comparator group

Description:

Tap water

Treatment:

Dietary Supplement: 3-hydroxybutyrate