Exogenous Ketones and Behavior (ExoKet)

German Institute of Human Nutrition

Status: Enrolling

Conditions: Behavior

Treatments: Dietary Supplement: dextrose (placebo); Dietary Supplement: ketone ester

Study type: Interventional

Funder types: Other

Identifiers

NCT06515717

ExoKet

Details and patient eligibility

About

The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.

Full description

This study investigates the effects of exogenous ketone ester on behavior, cognition, and metabolism over one week of consumption. Using a within-subjects, randomized, crossover design, participants will undergo two phases: one with the ketone ester supplement and one with a calorie- and taste-matched placebo. The study includes four lab visits: visits 1 and 3 mark the first day of each intervention, while visits 2 and 4 mark the last day. During each visit, participants will complete behavioral tasks, questionnaires, and blood tests. Additionally, participants will record their food intake via an app and collect stool samples throughout the intervention.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Consent to participate
• Fluent in German
• Physically healthy. No regular medication
• No drug use 1 week prior to the study
• BMI 18-31 kg/m2

Exclusion criteria

• Former or current illnesses of:
• Brain or mind (including eating disorders, personality disorders, alcohol, drugs or drug dependence, neurological disorders other than occasional headache; depression or anxiety disorder excluded)
• Heart or blood circulation
• Gastro-intestinal or endocrine disorders
• Liver or kidney disorders
• Electrolyte imbalance
• Other serious past or present medical conditions (for example, metabolic syndrome, diabetes, cancer)
• Pregnancy
• Extreme athletes (>2h/day intense work-out; casual cycling or walking is ok)
• Menopause (post menopause is ok)
• Ketogenic diet, ketogenic supplement intake, intermittent fasting or calorie restricted diet during preceding 4 weeks of study participation
• Fear of blood draw

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

ketone ester

Experimental group

Description:

Participants consume a ketone ester 3x per day for 8 days.

Treatment:

Dietary Supplement: ketone ester

Placebo containing dextrose

Placebo Comparator group

Description:

Participants consume a placebo 3x per day for 8 days. The placebo is matched in calories and taste to the ketone ester.

Treatment:

Dietary Supplement: dextrose (placebo)