KetosisMARKNCT04156477
Markers of Appetite Regulation During Exogenous Ketosis
A study testing Ketone ester, Glucose and Tap water in people with Ketosis, run by Central Jutland Regional Hospital at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the relationship, if any, between markers of satiety, desire to eat, hunger, and metabolic markers of the regulation hereof during ketosis as compared with a Glucose-containing and a Placebo drink adjusted for taste. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ketosis
- What is being tested?
- Ketone ester, Glucose and Tap water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Oct 2019to Dec 2019
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males aged 18-65 years
- BMI 20-35 kg/m2
- Expected ease of catheter insertion
- Oral and written informed consent
Who cannot join
- Inability to fully understand the consent including consent forms
- Inability to cooperate to the trial
- Any electrolyte disorders, kidney disease or otherwise compromised renal function including excess risk hereof, e.g. hypertension, albuminuria, autoimmune disease, family history of kidney disease
- Any liver or bile disease including excess risk hereof, e.g. hepatotoxic drugs, alcohol abuse disorder, gallstones, pancreatitis, autoimmune disease, family history of liver disease
- Diabetes mellitus or any metabolic and/or hormonal disease including diagnosed/undiagnosed reactive hypoglycemia or similar disorders. This includes treatment with drugs, dietary supplement with inference on key metabolic or hormonal markers, e.g. insulin, glukagon, lipids, and GLP-1
- Any use of illegal or otherwise use of medicinal products without prescription
Show all 11Show fewer
- Anemia or other know disease of the hematopoietic system
- Previous bariatric surgery
- Previous myocardial infarction or uncontrolled myocardial ischemia
- Recent intended/unintended weight loss
- Allergies to catheters or adhesives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Markers of Appetite Regulation During Exogenous Ketosis - a Placebo Controlled Randomized Study of Appetite Regulatory and Metabolic Markers After Intake of a Keto- or Glucogenic Drink.
The aim of this study is to investigate the relationship, if any, between markers of satiety, desire to eat, hunger, and metabolic markers of the regulation hereof during ketosis as compared with a Glucose-containing and a Placebo drink adjusted for taste.
Read the detailed description
All subjects are, in random order, tested on three separate occasions with intake of weight adjusted and taste matched drink of i) a ketone ester, and ii) an isocaloric and -volumetric glucose drink, or iii) an isovolumetric tap water drink.
Subjects are studied for five hours with baseline and blood sampling on multiple occasions. A satiety questionaire are included.
Subjects are recruited through notice on website for this purpose. Sample size calculations were performed prior to inclusion (n=10). According to protocolized statistical plan, missing data will not be replaced and no imputation will occur. Data will be analyzed by applying a repeated measurements multilevel model with intervention, time and their interactions as categorical factors. Effects size are adjusted for small sample size.
- Conditions
- Ketosis
- Being tested
- Ketone ester, Glucose, Tap water
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone esterDietary supplement
Intake of weight adjusted drink of a ketone ester
GlucoseDietary supplement
Isocaloric and - volumetric taste adjusted drink
Tap waterDietary supplement
Isovolumetric taste adjusted tap water (placebo)
| Study group | Role | What they receive |
|---|---|---|
| Ketone ester | Experimental | Intake of a ketogenic drink. Receives: Dietary Supplement: Ketone ester |
| Isocaloric and -volumetric glucose drink | Active comparator | Intake of a taste matched glucogenic drink. Receives: Dietary Supplement: Glucose |
| Isovolumetric tap water drink | Placebo comparator | Intake of a taste matched tap water drink. Receives: Dietary Supplement: Tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
GLP-1 concentration
Development of GLP-1 concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Measured: 5 hours
Acyl ghrelin concentration
Development of acyl ghrelin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Measured: 5 hours
Secondary outcomes (4)
Satiety, desire to eat, and perceived hunger sensation
Scores of satiety, desire to eat, and perceived hunger sensation during intervention all measured on a scale from 1-100 where 1 is the lowest score and 100 the highest.
Measured: 5 hours
Glucose concentration
Development of glucose concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Measured: 5 hours
Insulin concentration
Development of insulin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Measured: 5 hours
Free fatty acids concentration
Development of free fatty acids concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start24 Oct 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for KetosisStudies of the same condition, open and under way.
- 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
- Model description
- This is a experimental, randomized, single-center cross-over study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Jutland Regional Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik H Thomsen, M.D., PhD, Principal investigator, Viborg Region Hospital, Central Jutland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156477
- Sponsor's protocol ID
- 121953
- Acronym
- MARK
- Status last verified
- Oct 2019
- First submitted
- 18 Oct 2019
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Laeger T, Metges CC, Kuhla B. Role of beta-hydroxybutyric acid in the central regulation of energy balance. Appetite. 2010 Jun;54(3):450-5. doi: 10.1016/j.appet.2010.04.005. Epub 2010 Apr 21.
PubMed 20416348Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.
PubMed 29163194Myette-Cote E, Neudorf H, Rafiei H, Clarke K, Little JP. Prior ingestion of exogenous ketone monoester attenuates the glycaemic response to an oral glucose tolerance test in healthy young individuals. J Physiol. 2018 Apr 15;596(8):1385-1395. doi: 10.1113/JP275709. Epub 2018 Mar 2.
PubMed 29446830Svart M, Rittig N, Luong TV, Gopalasingam N, Vestergaard ET, Gormsen L, Sondergaard E, Thomsen HH, Gravholt CH. Three Weeks on a Ketogenic Diet Reduces Free Testosterone and Free Estradiol in Middle-Aged Obese Men and Women. J Nutr Metab. 2024 Aug 6;2024:9301369. doi: 10.1155/2024/9301369. eCollection 2024.
PubMed 39139216
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Appetite Regulation During Exogenous Ketosis - a Placebo Controlled Randomized Study of Appetite Regulatory and Metabolic Markers After Intake of a Keto- or Glucogenic Drink.
- ClinicalTrials.gov ID
- NCT04156477
- Acronym / sponsor ID
- MARK / 121953
- Conditions
- Ketosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Central Jutland Regional HospitalUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Nov 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.
The aim of this study is to investigate the relationship, if any, between markers of satiety, desire to eat, hunger, and metabolic markers of the regulation hereof during ketosis as compared with a Glucose-containing and a Placebo drink adjusted for taste.
Detailed description
All subjects are, in random order, tested on three separate occasions with intake of weight adjusted and taste matched drink of i) a ketone ester, and ii) an isocaloric and -volumetric glucose drink, or iii) an isovolumetric tap water drink.
Subjects are studied for five hours with baseline and blood sampling on multiple occasions. A satiety questionaire are included.
Subjects are recruited through notice on website for this purpose. Sample size calculations were performed prior to inclusion (n=10). According to protocolized statistical plan, missing data will not be replaced and no imputation will occur. Data will be analyzed by applying a repeated measurements multilevel model with intervention, time and their interactions as categorical factors. Effects size are adjusted for small sample size.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a experimental, randomized, single-center cross-over study.
| Arm | Type | Receives |
|---|---|---|
| Ketone ester | Experimental | Dietary Supplement: Ketone esterIntake of a ketogenic drink. |
| Isocaloric and -volumetric glucose drink | Active comparator | Dietary Supplement: GlucoseIntake of a taste matched glucogenic drink. |
| Isovolumetric tap water drink | Placebo comparator | Dietary Supplement: Tap waterIntake of a taste matched tap water drink. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males aged 18-65 years
- BMI 20-35 kg/m2
- Expected ease of catheter insertion
- Oral and written informed consent
Key exclusion criteria (11 listed)
- Inability to fully understand the consent including consent forms
- Inability to cooperate to the trial
- Any electrolyte disorders, kidney disease or otherwise compromised renal function including excess risk hereof, e.g. hypertension, albuminuria, autoimmune disease, family history of kidney disease
- Any liver or bile disease including excess risk hereof, e.g. hepatotoxic drugs, alcohol abuse disorder, gallstones, pancreatitis, autoimmune disease, family history of liver disease
- Diabetes mellitus or any metabolic and/or hormonal disease including diagnosed/undiagnosed reactive hypoglycemia or similar disorders. This includes treatment with drugs, dietary supplement with inference on key metabolic or hormonal markers, e.g. insulin, glukagon, lipids, and GLP-1
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 |
|---|---|---|
| Ketone esterIntake of weight adjusted drink of a ketone ester | Dietary supplement | Ketone ester |
| GlucoseIsocaloric and - volumetric taste adjusted drink | Dietary supplement | Isocaloric and -volumetric glucose drink |
| Tap waterIsovolumetric taste adjusted tap water (placebo) | Dietary supplement | Isovolumetric tap water drink |
Primary outcome
GLP-1 concentration
Time frame: 5 hours
Development of GLP-1 concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Acyl ghrelin concentration
Time frame: 5 hours
Development of acyl ghrelin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
4 secondary outcomes
Satiety, desire to eat, and perceived hunger sensation
Time frame: 5 hours
Glucose concentration
Time frame: 5 hours
Insulin concentration
Time frame: 5 hours
Free fatty acids concentration
Time frame: 5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- Background: PubMed 20416348Laeger T, Metges CC, Kuhla B. Role of beta-hydroxybutyric acid in the central regulation of energy balance. Appetite. 2010 Jun;54(3):450-5. doi: 10.1016/j.appet.2010.04.005. Epub 2010 Apr 21.
- Background: PubMed 29163194Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.
- Background: PubMed 29446830Myette-Cote E, Neudorf H, Rafiei H, Clarke K, Little JP. Prior ingestion of exogenous ketone monoester attenuates the glycaemic response to an oral glucose tolerance test in healthy young individuals. J Physiol. 2018 Apr 15;596(8):1385-1395. doi: 10.1113/JP275709. Epub 2018 Mar 2.
- Derived from this study: PubMed 39139216Svart M, Rittig N, Luong TV, Gopalasingam N, Vestergaard ET, Gormsen L, Sondergaard E, Thomsen HH, Gravholt CH. Three Weeks on a Ketogenic Diet Reduces Free Testosterone and Free Estradiol in Middle-Aged Obese Men and Women. J Nutr Metab. 2024 Aug 6;2024:9301369. doi: 10.1155/2024/9301369. eCollection 2024.
- 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.
Henrik H Thomsen, M.D., PhD principal investigator
Viborg Region Hospital, Central Jutland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone ester, Glucose and Tap water in people with Ketosis, run by Central Jutland Regional Hospital 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 11 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: status not confirmed, as of the sponsor's last update on 15 Nov 2019. 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?
Results are not available in the source record.
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?
GLP-1 concentration (time frame: 5 hours). The study lists 2 primary outcomes in all. 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 NCT04156477, which also lists 4 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 15 Nov 2019.