Markers of Appetite Regulation During Exogenous Ketosis

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 2019

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 Supplement: Ketone ester
    • Intake of weight adjusted drink of a ketone ester
  • Dietary Supplement: Glucose
    • Isocaloric and – volumetric taste adjusted drink
  • Dietary Supplement: Tap water
    • Isovolumetric taste adjusted tap water (placebo)

Arms, Groups and Cohorts

  • Experimental: Ketone ester
    • Intake of a ketogenic drink.
  • Active Comparator: Isocaloric and -volumetric glucose drink
    • Intake of a taste matched glucogenic drink.
  • Placebo Comparator: Isovolumetric tap water drink
    • Intake of a taste matched tap water drink.

Clinical Trial Outcome Measures

Primary Measures

  • GLP-1 concentration
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Satiety, desire to eat, and perceived hunger sensation
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Central Jutland Regional Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Henrik H Thomsen, M.D., PhD, Principal Investigator, Viborg Region Hospital, Central Jutland

References

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. Review.

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.

Myette-Côté É, 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.

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