Markers of Appetite Regulation During Exogenous Ketosis

Not Applicable

• Conditions: Ketosis
• Interventions: Dietary Supplement: Tap water; Dietary Supplement: Glucose; Dietary Supplement: Ketone ester

• Registration Number: NCT04156477
• Lead Sponsor: Central Jutland Regional Hospital

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-18
• Study Start: 2019-10-24
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-11-15
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isovolumetric tap water drink	Tap water	Intake of a taste matched tap water drink.
Isocaloric and -volumetric glucose drink	Glucose	Intake of a taste matched glucogenic drink.
Ketone ester	Ketone ester	Intake of a ketogenic drink.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Regionshospitalet Viborg; 🇩🇰 Viborg, Denmark