Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).
1 other identifier
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2019
CompletedFirst Posted
Study publicly available on registry
May 2, 2019
CompletedStudy Start
First participant enrolled
June 7, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedNovember 3, 2020
November 1, 2020
5 months
April 29, 2019
November 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
plasma insulin
incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l}
180 minutes
Secondary Outcomes (16)
Plasma Glucagon
180 minutes
Gastric emptying
180 minutes
Urine 3-OHB
180 minutes
Plasma GLP1
180 minutes
Plasma GIP
180 minutes
- +11 more secondary outcomes
Study Arms (2)
3-OHB orally
EXPERIMENTAL36 gram 3-OHB salt consumed orally
3-OHB intravenously
ACTIVE COMPARATORVariable amounts of 3-OHB salt given i order to replicate the same individual plasma concentrations measured during the experimental arm.
Interventions
36 gram 3-OHB salt diluted in 500 ml sterile water
Eligibility Criteria
You may qualify if:
- healthy
- \<BMI\<30
- written og oral consent
- No allergies to paracetamol
You may not qualify if:
- Chronic disease or daily medical treatment
- Daily intake of ketones or ketogenic diets
- Speaks and understands Danish
- Screening blood sample abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Diabetes and Hormone Diseases (DoH)
Aarhus N, 8200, Denmark
Related Publications (2)
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.
PMID: 37844838DERIVEDRittig 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.
PMID: 32717058DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Niels Jessen, Professor
Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator, MD, PhD, and clinical researcher
Study Record Dates
First Submitted
April 29, 2019
First Posted
May 2, 2019
Study Start
June 7, 2019
Primary Completion
November 1, 2019
Study Completion
March 1, 2020
Last Updated
November 3, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share