Markers of Appetite Regulation During Exogenous Ketosis

Ketosis Clinical Trial

— MARK  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04156477
• Other study ID #: 121953
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: December 2019

Study information

• Verified date: October 2019
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketosis

Intervention

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

Locations

Country	Name	City	State
Denmark	Regionshospitalet Viborg	Viborg

Sponsors (1)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Glucose concentration	Development of glucose concentration during ketosis as compared after intake of a ketogenic vs a glucogenic drink vs a control drink, respectively.	5 hours
Secondary	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
Secondary	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