Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).

University of Aarhus

Status: Completed

Conditions: Healthy; Ketosis; Incretin Effect

Treatments: Dietary Supplement: 3-OHB salt (NaCl)

Study type: Interventional

Funder types: Other

Identifiers

NCT03935841

1-10-72-56-19

Details and patient eligibility

About

An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions:

1. blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
2. blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the concentrations seen during oral consumption.

The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes after 3-OHB consumed orally vs. intravenously.

Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg Paracetamol consumption before each intervention day. Urine will be analyzed for ketone concentrations/excretion rates.

Full description

An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions with at least 48 hours apart.

1. blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
2. blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the concentrations seen during oral consumption.

The primary outcome is differences in insulin concentrations (incremental AUC) 180 minutes after 3-OHB consumed orally vs. intravenously.

Secondary outcomes includes iAUC for other gastrointestinal hormones and substrates (Glucagon, GLP-1, GIP, glucose, and 3-OHB) Gastric emptying will be evaluated using 1500 mg Paracetamol consumption before each intervention day. Urine will be analyzed for ketone concentrations/excretion rates.

Enrollment: 8 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy
• 19<BMI<30
• written og oral consent
• No allergies to paracetamol

Exclusion criteria

• Chronic disease or daily medical treatment
• Daily intake of ketones or ketogenic diets
• Speaks and understands Danish
• Screening blood sample abnormalities

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

3-OHB orally

Experimental group

Description:

36 gram 3-OHB salt consumed orally

Treatment:

Dietary Supplement: 3-OHB salt (NaCl)

3-OHB intravenously

Active Comparator group

Description:

Variable amounts of 3-OHB salt given i order to replicate the same individual plasma concentrations measured during the experimental arm.

Treatment:

Dietary Supplement: 3-OHB salt (NaCl)