Back to resultsMarkers of Appetite Regulation During Exogenous Ketosis (MARK)
Primary Purpose
Ketosis
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ketone ester
Glucose
Tap water
Sponsored by
About this trial
This is an interventional basic science trial for Ketosis
Eligibility Criteria
Inclusion Criteria:
- Males aged 18-65 years
- BMI 20-35 kg/m2
- Expected ease of catheter insertion
- Oral and written informed consent
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Regionshospitalet Viborg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Ketone ester
Isocaloric and -volumetric glucose drink
Isovolumetric tap water drink
Arm Description
Intake of a ketogenic drink.
Intake of a taste matched glucogenic drink.
Intake of a taste matched tap water drink.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Glucose concentration
Development of glucose concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Insulin concentration
Development of insulin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
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.
Full Information
NCT ID
NCT04156477
First Posted
October 18, 2019
Last Updated
November 14, 2019
Sponsor
Central Jutland Regional Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04156477
Brief Title
Markers of Appetite Regulation During Exogenous Ketosis
Acronym
MARK
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Jutland Regional Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a experimental, randomized, single-center cross-over study.
Masking
Participant
Masking 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 (HVMN Ketone, 38 Mason St, 3rd Floor, San Francisco, CA 94102, USA) and ii) an isocaloric and -volumetric glucose drink, or iii) an isovolumetric tap water drink. Taste matching for the latter two are done by adding of a bitterness additive (Bitrex, Integriertes Trademarketing GmbH Herderstraße 16, 23564 Lübeck, Germany) with additional adding Stevia (Bodylab Stevia Drops; Bodylab,Plastvænget 3D, 9650 Hadsund, Denmark) for the tap water drink. Subjects will subsequently drink 50 mL of zero-calorie drink (Gatorade (Gatorade Company, Inc., Chicago, IL, USA) in order to eliminate any remaining flavour of the intervention drinks.
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketone ester
Arm Type
Experimental
Arm Description
Intake of a ketogenic drink.
Arm Title
Isocaloric and -volumetric glucose drink
Arm Type
Active Comparator
Arm Description
Intake of a taste matched glucogenic drink.
Arm Title
Isovolumetric tap water drink
Arm Type
Placebo Comparator
Arm Description
Intake of a taste matched tap water drink.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone ester
Intervention Description
Intake of weight adjusted drink of a ketone ester
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
Isocaloric and - volumetric taste adjusted drink
Intervention Type
Dietary Supplement
Intervention Name(s)
Tap water
Intervention Description
Isovolumetric taste adjusted tap water (placebo)
Primary Outcome Measure Information:
Title
GLP-1 concentration
Description
Development of GLP-1 concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Time Frame
5 hours
Title
Acyl ghrelin concentration
Description
Development of acyl ghrelin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Satiety, desire to eat, and perceived hunger sensation
Description
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.
Time Frame
5 hours
Title
Glucose concentration
Description
Development of glucose concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Time Frame
5 hours
Title
Insulin concentration
Description
Development of insulin concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Time Frame
5 hours
Title
Free fatty acids concentration
Description
Development of free fatty acids concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.
Time Frame
5 hours
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males aged 18-65 years
BMI 20-35 kg/m2
Expected ease of catheter insertion
Oral and written informed consent
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik H Thomsen, M.D., PhD
Organizational Affiliation
Viborg Region Hospital, Central Jutland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regionshospitalet Viborg
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20416348
Citation
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.
Results Reference
background
PubMed Identifier
29163194
Citation
Stubbs 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.
Results Reference
background
PubMed Identifier
29446830
Citation
Myette-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. Erratum In: J Physiol. 2019 Nov;597(22):5515. Abstract corrected.
Results Reference
background
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Markers of Appetite Regulation During Exogenous Ketosis
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