Acute KetosisNCT02917252
How Orally Consumed 3-hydroxybuturate Alters Metabolism
A study testing 3-hydroxybuturate in people with Acute Ketosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
This study evaluate the metabolic effects of orally ingested ketone bodies. The study is conducted as a randomized, cross over study. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Acute Ketosis
- What is being tested?
- 3-hydroxybuturate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2017to 3 Apr 2017
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 20-30
Who cannot join
- Smoking
- alcohol or drug abuse
- Critically ill
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketone Bodies Ingested Orally Alter Metabolism for Glucose, Lipid, and Protein
This study evaluate the metabolic effects of orally ingested ketone bodies. The study is conducted as a randomized, cross over study.
Read the detailed description
Subject participate for two separate days; i) intervention, ii) placebo. Intervention: subjects drink ketone body solution. Tracer kinetics on glucose and lipid metabolism is applied. Muscle tissue and adipose tissue biopsies are taken.
Placebo: subjects drink saline. Same sampling as on intervention day.
- Conditions
- Acute Ketosis
- Being tested
- 3-hydroxybuturate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-hydroxybuturateOther
Drink of ketone bodies
PlaceboOther
Drink of saline
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Subjects drink 3-hydroxybuturate Receives: Other: 3-hydroxybuturate |
| Placebo | Placebo comparator | Subjects drink saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-hydroxybuturate
blood level of 3-hydroxybuturate
Measured: 0-270 minutes
Secondary outcomes (2)
Glucose
Glucose tracer kinetics, endogenous glucose production, muscle biopsy
Measured: 0-270 minutes
lipid metabolism
Palmitate tracer kinetics, free fatty acid accumulation, adipose tissue biopsies
Measured: 0-270 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start1 Feb 2017
- Primary completion3 Apr 2017
- Study completion3 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute KetosisStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917252
- Sponsor's protocol ID
- RM-1-10-72-157-16
- Status last verified
- Sep 2016
- First submitted
- 27 Sep 2016
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Svart M, Rittig N, Pedersen SB, Jessen N, Moller N. Oral 3-hydroxybutyrate ingestion decreases endogenous glucose production, lipolysis, and hormone-sensitive lipase phosphorylation in adipose tissue in men: a human randomized, controlled, crossover trial. Diabet Med. 2021 Feb;38(2):e14385. doi: 10.1111/dme.14385. Epub 2020 Sep 22.
PubMed 32794582
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketone Bodies Ingested Orally Alter Metabolism for Glucose, Lipid, and Protein
- ClinicalTrials.gov ID
- NCT02917252
- Acronym / sponsor ID
- RM-1-10-72-157-16
- Conditions
- Acute Ketosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 28 Sep 2016 (estimated)
- 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.
This study evaluate the metabolic effects of orally ingested ketone bodies. The study is conducted as a randomized, cross over study.
Detailed description
Subject participate for two separate days; i) intervention, ii) placebo. Intervention: subjects drink ketone body solution. Tracer kinetics on glucose and lipid metabolism is applied. Muscle tissue and adipose tissue biopsies are taken.
Placebo: subjects drink saline. Same sampling as on intervention day.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: 3-hydroxybuturateSubjects drink 3-hydroxybuturate |
| Placebo | Placebo comparator | Other: PlaceboSubjects drink saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- BMI 20-30
Key exclusion criteria (3 listed)
- Smoking
- alcohol or drug abuse
- Critically ill
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-hydroxybuturateDrink of ketone bodies | Other | Intervention |
| PlaceboDrink of saline | Other | Placebo |
Primary outcome
3-hydroxybuturate
Time frame: 0-270 minutes
blood level of 3-hydroxybuturate
2 secondary outcomes
Glucose
Time frame: 0-270 minutes
lipid metabolism
Time frame: 0-270 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 10 Apr 2017.
- Derived from this study: PubMed 32794582Svart M, Rittig N, Pedersen SB, Jessen N, Moller N. Oral 3-hydroxybutyrate ingestion decreases endogenous glucose production, lipolysis, and hormone-sensitive lipase phosphorylation in adipose tissue in men: a human randomized, controlled, crossover trial. Diabet Med. 2021 Feb;38(2):e14385. doi: 10.1111/dme.14385. Epub 2020 Sep 22.
- Individual participant dataSharing planned: No
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Post-exercise Period, Ketosis
Not yet recruiting
Acute Effects of Ketone Monoester Co-Ingestion With Dietary Protein on Whole-Body Phenylalanine Oxidation, Phenylalanine Retention, and Myofibrillar Protein Breakdown Following Resistance Exercise in Older Males
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Effects of Ketone Supplement and Alcohol on Brain Metabolism
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Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure
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Effects of Ketone Supplementation on Acute Alcohol Withdrawal
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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.
The record lists no contact. Use the official record to reach the sponsor.
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-hydroxybuturate in people with Acute Ketosis, 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 1 inclusion and 3 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 10 Apr 2017. 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. Some participants in this study may receive a placebo. 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?
3-hydroxybuturate (time frame: 0-270 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 NCT02917252, which also lists 1 linked publication.
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 10 Apr 2017.