HealthyNCT03935841
Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).
A study testing 3-OHB salt (NaCl) in people with Healthy and Incretin Effect, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Incretin Effect, Ketosis
- What is being tested?
- 3-OHB salt (NaCl)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Jun 2019to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- 19<BMI<30
- written og oral consent
- No allergies to paracetamol
Who cannot join
- Chronic disease or daily medical treatment
- Daily intake of ketones or ketogenic diets
- Speaks and understands Danish
- Screening blood sample abnormalities
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Diabetes and Hormone Diseases (DoH)
Aarhus N, 8200
About this study
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions:
- blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
- blood sampling while given a variable rate of 3-OHB salt intravenously to replicate the concentrations seen during oral consumption.
Read more
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.
Read the detailed description
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions with at least 48 hours apart.
- blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
- 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
- Healthy, Incretin Effect, Ketosis
- Being tested
- 3-OHB salt (NaCl)
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-OHB salt (NaCl)Dietary supplement
36 gram 3-OHB salt diluted in 500 ml sterile water
| Study group | Role | What they receive |
|---|---|---|
| 3-OHB orally | Experimental | 36 gram 3-OHB salt consumed orally Receives: Dietary Supplement: 3-OHB salt (NaCl) |
| 3-OHB intravenously | Active comparator | Variable amounts of 3-OHB salt given i order to replicate the same individual plasma concentrations measured during the experimental arm. Receives: Dietary Supplement: 3-OHB salt (NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma insulin
incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l}
Measured: 180 minutes
Secondary outcomes (16)
Plasma Glucagon
iAUC and concentrations of (Glucagon {pg/ml}
Measured: 180 minutes
Gastric emptying
Paracetamol test, 1500 mg following interventions and measuring plasma paracetamol {micromol/l}
Measured: 180 minutes
Urine 3-OHB
Excretion rates {gram/hour} will be estimated as = urine output {L} x urine 3-OHB concentration {mmol/l} x 0.1041 {g/mmol}/180 minutes
Measured: 180 minutes
Plasma GLP1
iAUC and concentrations of GLP-1 {pmol/l},
Measured: 180 minutes
Plasma GIP
iAUC and concentrations of GIP {pmol/l},
Measured: 180 minutes
Plasma glucose
iAUC and concentrations of glucose {mmol/l},
Measured: 180 minutes
Plasma free fatty acids
iAUC and concentrations of free fatty acids {mmol/l},
Measured: 180 minutes
Plasma 3-OHB
iAUC and concentrations of 3-OHB {mmol/l})
Measured: 180 minutes
Plasma Ghrelin
iAUC and concentrations of Ghrelin {ng/l})
Measured: 180 minutes
Plasma PYY
iAUC and concentrations of PYY {pg/ml})
Measured: 180 minutes
height
height {meters}
Measured: at time 0 minutes
weight
weight {kg}
Measured: at time 0 minutes
BMI
Body mass index = weight/height^2
Measured: time 0 minutes
Blood pressure
Arm blood pressure
Measured: time 0 minutes and 180 minutes
Satiety questionnaire (Blundell et al. 2010)
VAS/NRS-score of hunger, fullness, satiety, desire, and prospective consumption
Measured: At 0, 60, 120, and 180 minutes
Ad libitum food intake
gram (and kcal) intake of an ad libitum meal (sandwich)
Measured: at time = 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start7 Jun 2019
- Primary completion1 Nov 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaj Fibiger Rittig, University of Aarhus
- Investigators
- Niels Jessen, Professor, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935841
- Sponsor's protocol ID
- 1-10-72-56-19
- Status last verified
- Nov 2020
- First submitted
- 29 Apr 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pedersen MGB, Ghias E, Bangshaab M, Loung TV, Bengtsen MB, Svart MV, Sondergaard E, Gormsen LC, Moller N, Johannsen M, Rittig N. Ketosis elevates plasma concentrations of D-beta-hydroxybutyryl-phenylalanine (BHB-Phe) in humans. Nutr Metab (Lond). 2026 Jul 15. doi: 10.1186/s12986-026-01172-7. Online ahead of print.
PubMed 42458538Pedersen 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.
PubMed 37844838Rittig 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.
PubMed 32717058
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Differences of an Oral and Intravenous Dose of 3-hydroxybutyrate (3-OHB).
- ClinicalTrials.gov ID
- NCT03935841
- Acronym / sponsor ID
- 1-10-72-56-19
- Conditions
- Healthy, Incretin Effect, Ketosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions:
- blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
- 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
An open-labeled intervention study testing healthy, lean, and male volunteers on two separate occasions with at least 48 hours apart.
- blood sampling after consuming 36 gram 3-Hydroxybutyrate (3-OHB) salt.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3-OHB orally | Experimental | Dietary Supplement: 3-OHB salt (NaCl)36 gram 3-OHB salt consumed orally |
| 3-OHB intravenously | Active comparator | Dietary Supplement: 3-OHB salt (NaCl)Variable amounts of 3-OHB salt given i order to replicate the same individual plasma concentrations measured during the experimental arm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy
- 19<BMI<30
- written og oral consent
- No allergies to paracetamol
Key exclusion criteria (4 listed)
- Chronic disease or daily medical treatment
- Daily intake of ketones or ketogenic diets
- Speaks and understands Danish
- Screening blood sample abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-OHB salt (NaCl)36 gram 3-OHB salt diluted in 500 ml sterile water | Dietary supplement | 3-OHB intravenously, 3-OHB orally |
Primary outcome
plasma insulin
Time frame: 180 minutes
incremental area under the curve (iAUC) for plasma insulin concentrations {pmol/l}
16 secondary outcomes
Plasma Glucagon
Time frame: 180 minutes
Gastric emptying
Time frame: 180 minutes
Urine 3-OHB
Time frame: 180 minutes
Plasma GLP1
Time frame: 180 minutes
Plasma GIP
Time frame: 180 minutes
Plasma glucose
Time frame: 180 minutes
Plasma free fatty acids
Time frame: 180 minutes
Plasma 3-OHB
Time frame: 180 minutes
Plasma Ghrelin
Time frame: 180 minutes
Plasma PYY
Time frame: 180 minutes
height
Time frame: at time 0 minutes
weight
Time frame: at time 0 minutes
BMI
Time frame: time 0 minutes
Blood pressure
Time frame: time 0 minutes and 180 minutes
Satiety questionnaire (Blundell et al. 2010)
Time frame: At 0, 60, 120, and 180 minutes
Ad libitum food intake
Time frame: at time = 180 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Derived from this study: PubMed 42458538Pedersen MGB, Ghias E, Bangshaab M, Loung TV, Bengtsen MB, Svart MV, Sondergaard E, Gormsen LC, Moller N, Johannsen M, Rittig N. Ketosis elevates plasma concentrations of D-beta-hydroxybutyryl-phenylalanine (BHB-Phe) in humans. Nutr Metab (Lond). 2026 Jul 15. doi: 10.1186/s12986-026-01172-7. Online ahead of print.
- Derived from this study: PubMed 37844838Pedersen 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.
- Derived from this study: PubMed 32717058Rittig 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niels Jessen, Professor study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-OHB salt (NaCl) in people with Healthy and Incretin Effect, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma insulin (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935841, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.