Ketosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKetone ester
Intake of weight adjusted drink of a ketone ester
DIETARY_SUPPLEMENTGlucose
Isocaloric and - volumetric taste adjusted drink
DIETARY_SUPPLEMENTTap water
Isovolumetric taste adjusted tap water (placebo)
Sponsors
Central Jutland Regional Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
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.
Intervention model description
This is a experimental, randomized, single-center cross-over study.
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GLP-1 concentration | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satiety, desire to eat, and perceived hunger sensation | 5 hours | 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 | 5 hours | Development of glucose concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively. |
| Insulin concentration | 5 hours | 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 | 5 hours | Development of free fatty acids concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively. |
Countries
Denmark
Outcome results
None listed