Markers of Appetite Regulation During Exogenous Ketosis (MARK)

Central Jutland Regional Hospital

Status: Unknown

Conditions: Ketosis

Treatments: Dietary Supplement: Glucose; Dietary Supplement: Ketone ester; Dietary Supplement: Tap water

Study type: Interventional

Funder types: Other

Identifiers

NCT04156477

121953

Details and patient eligibility

About

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 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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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10 participants in 3 patient groups, including a placebo group

Ketone ester

Experimental group

Description:

Intake of a ketogenic drink.

Treatment:

Dietary Supplement: Ketone ester

Isocaloric and -volumetric glucose drink

Active Comparator group

Description:

Intake of a taste matched glucogenic drink.

Treatment:

Dietary Supplement: Glucose

Isovolumetric tap water drink

Placebo Comparator group

Description:

Intake of a taste matched tap water drink.

Treatment:

Dietary Supplement: Tap water