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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone ester | Experimental | Intake of a ketogenic drink. |
|
| Isocaloric and -volumetric glucose drink | Active Comparator | Intake of a taste matched glucogenic drink. |
|
| Isovolumetric tap water drink | Placebo Comparator | Intake of a taste matched tap water drink. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone ester | Dietary Supplement | Intake of weight adjusted drink of a ketone ester |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 hours |
| Glucose concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik H Thomsen, M.D., PhD | Viborg Region Hospital, Central Jutland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regionshospitalet Viborg | Viborg | 8800 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20416348 | Background | 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. | |
| 29163194 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 21, 2022 | |
| Reset | Aug 7, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 21, 2022 | Aug 7, 2023 |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C524675 | formic acid 4-(3-oxobutyl)phenyl ester |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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This is a experimental, randomized, single-center cross-over study.
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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.
| Glucose |
| Dietary Supplement |
Isocaloric and - volumetric taste adjusted drink |
|
| Tap water | Dietary Supplement | Isovolumetric taste adjusted tap water (placebo) |
|
Development of glucose concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively. |
| 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. | 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. | 5 hours |
| 29446830 | Background | 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. |
| 39139216 | Derived | Svart 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. |