An interventional study of Ketone ester and Glucose in Ketosis, sponsored by Central Jutland Regional Hospital. Status unknown at 1 site in Denmark. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-15.
Sponsored by Central Jutland Regional Hospital · Not applicable, Interventional, and Basic science
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.
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.
195 studies on the registry are indexed under Ketosis; 41 are open to participants now.
This study's enrollment of 10 is below the median of 24 across 156 interventional studies indexed under Ketosis.
Browse Ketosis studies →Central Jutland Regional Hospital is the lead sponsor of 32 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intake of a ketogenic drink.
Dietary Supplement: Ketone ester
Intake of a taste matched glucogenic drink.
Dietary Supplement: Glucose
Intake of a taste matched tap water drink.
Dietary Supplement: Tap water
Intake of weight adjusted drink of a ketone ester
Isocaloric and - volumetric taste adjusted drink
Isovolumetric taste adjusted tap water (placebo)
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.
Time frame: 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.
Time frame: 5 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 hours
Plan to share: No
Started Oct 2019 (actual). Primary completion is estimated for Dec 2019, 2 months after the start.
Of 76 non-industry interventional studies with no phase under Ketosis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's planned 2 months is below that.
Counting every sponsor, half of 79 studies reached it within 14 months; a quarter within 7 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beta-hydroxybutyrate-1,3-butanediol monoester
Central Jutland Regional Hospital