Exogenous Ketones and Behavior
ConditionBehavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorGerman Institute of Human Nutrition
About this trial
The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Consent to participate
Fluent in German
Physically healthy. No regular medication
No drug use 1 week prior to the study
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
ketone ester
Dietary supplementoral supplement
dextrose (placebo)
Dietary supplementoral supplement calorie and taste matched to ketone supplement
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: ketone esterExperimental treatment 1 intervention
Group B: Placebo containing dextrosePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anxiety behavior in Virtual Reality
Using different scenes in Virtual Reality, parameters of motion behavior such as speed (measured in meters per second) and distance walked (measured in meters) will be assessed using motion tracking technology. These measurements will be combined to generate a composite score of anxiety-related motion behavior.
Time frame
on day 8 of each intervention arm (visit 2 and 4)2
Risk propensity on a decision-making task
The choice (accept/reject) between a risk/gamble or safe option, based on a task paradigm by Liu et al. (2021)
Time frame
on day 8 of each intervention arm (visit 2 and 4)3
Competitive confidence in a competition task
based on a task paradigm by Goette et al., 2015
Time frame
on day 8 of each intervention arm (visit 2 and 4)4
Delay Discounting behavior in a computerized task
based on a task paradigm by Eisenstein et al. 2015
Time frame
on day 1 of each intervention arm (visit 1 and 3)Secondary outcomes
1
Gut microbiome
Assessed via stool samples after each intervention
Time frame
on day 8 of each intervention arm (visit 2 and 4)2
Daily food intake
Self-reported food intake recorded via FoodApp or handwritten food diary
Time frame
5 days of each intervention arm3
Trait Anxiety Questionnaire
Trait version of State-Trait Anxiety Inventory (STAI; Grimm et al. 2009). High scores mean high trait anxiety.
Time frame
baseline before visit 14
State Anxiety Questionnaire
State version of State-Trait Anxiety Inventory (STAI; Grimm et al. 2009). High scores mean high state anxiety.
Time frame
on day 1 and 8 of each intervention arm (visit 1,2,3,4)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov