Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).
NCT ID: NCT03935841
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2019-06-07
2020-03-01
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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3-OHB orally
36 gram 3-OHB salt consumed orally
3-OHB salt (NaCl)
36 gram 3-OHB salt diluted in 500 ml sterile water
3-OHB intravenously
Variable amounts of 3-OHB salt given i order to replicate the same individual plasma concentrations measured during the experimental arm.
3-OHB salt (NaCl)
36 gram 3-OHB salt diluted in 500 ml sterile water
Interventions
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3-OHB salt (NaCl)
36 gram 3-OHB salt diluted in 500 ml sterile water
Eligibility Criteria
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Inclusion Criteria
* 19\<BMI\<30
* written og oral consent
* No allergies to paracetamol
Exclusion Criteria
* Daily intake of ketones or ketogenic diets
* Speaks and understands Danish
* Screening blood sample abnormalities
18 Years
50 Years
MALE
Yes
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Nikolaj Fibiger Rittig
Principal investigator, MD, PhD, and clinical researcher
Principal Investigators
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Niels Jessen, Professor
Role: STUDY_DIRECTOR
Aarhus University Hospital
Locations
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Department of Diabetes and Hormone Diseases (DoH)
Aarhus N, , Denmark
Countries
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References
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Pedersen MGB, Lauritzen ES, Svart MV, Stoy J, Sondergaard E, Thomsen HH, Kampmann U, Bjerre M, Jessen N, Moller N, Rittig N. Nutrient sensing: LEAP2 concentration in response to fasting, glucose, lactate, and beta-hydroxybutyrate in healthy young males. Am J Clin Nutr. 2023 Dec;118(6):1091-1098. doi: 10.1016/j.ajcnut.2023.10.007. Epub 2023 Oct 14.
Rittig N, Svart M, Thomsen HH, Vestergaard ET, Rehfeld JF, Hartmann B, Holst JJ, Johannsen M, Moller N, Jessen N. Oral D/L-3-Hydroxybutyrate Stimulates Cholecystokinin and Insulin Secretion and Slows Gastric Emptying in Healthy Males. J Clin Endocrinol Metab. 2020 Oct 1;105(10):dgaa483. doi: 10.1210/clinem/dgaa483.
Other Identifiers
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1-10-72-56-19
Identifier Type: -
Identifier Source: org_study_id