Clinical trial NCT04156477: Markers of Appetite Regulation During Exogenous Ketosis
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
Overall status: UNKNOWN
Phase: NA
Conditions: Ketosis
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a experimental, randomized, single-center cross-over study.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: GLP-1 concentration
timeFrame: 5 hours
measure: Acyl ghrelin concentration
timeFrame: 5 hours
Secondary outcomes:
measure: Satiety, desire to eat, and perceived hunger sensation
timeFrame: 5 hours
measure: Glucose concentration
timeFrame: 5 hours
measure: Insulin concentration
timeFrame: 5 hours
measure: Free fatty acids concentration
timeFrame: 5 hours
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Regionshospitalet Viborg
Study officials:
affiliation: Viborg Region Hospital, Central Jutland
name: Henrik H Thomsen, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.