Exogenous Ketones and Behavior
NCT Number: NCT06515717
Acronym: ExoKet
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Behavior
Interventions: DIETARY_SUPPLEMENT: ketone ester|DIETARY_SUPPLEMENT: dextrose (placebo)
Sponsor: German Institute of Human Nutrition
Sex: ALL
Age: ADULT
Enrollment: 45
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-07-18
Completion Date: 2025-06-23
Locations: German Institute of Human Nutrition, Potsdam, Brandenburg, 14558, Germany

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

Primary Outcome Measures: 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., on day 8 of each intervention arm (visit 2 and 4)|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), on day 8 of each intervention arm (visit 2 and 4)|Competitive confidence in a competition task, based on a task paradigm by Goette et al., 2015, on day 8 of each intervention arm (visit 2 and 4)|Delay Discounting behavior in a computerized task, based on a task paradigm by Eisenstein et al. 2015, on day 1 of each intervention arm (visit 1 and 3)|Performance in Dual Task, based on a task paradigm by Szameitat et al., 2002, on day 1 of each intervention arm (visit 1 and 3)|Levels of ketones (ß-Hydroxybutyrate), Blood samples, baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits|Insulin, Blood samples, baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits|Ghrelin, Blood samples, baseline and + 90 minutes post drink-consumption on each of the 4 visits|Glucose Values, Continuous Glucose Monitoring through sensors applied to skin, every 15 Minutes from visit 1 to visit 2 and again from visit 3 to visit 4|Blood Glucose, Blood samples, baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits|Levels of cortisol, Blood samples, baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits|Electrocardiogram (heart rate), Electrophysiological recording, between 30 and 60 minutes post drink-consumption on each of the 4 visits|Electrocardiogram (heart rate variability), Electrophysiological recordings, between 30 and 60 minutes post drink-consumption on each of the 4 visits|Electrodermal Activity, Electrophysiological recordings, between 30 and 60 minutes post drink-consumption on each of the 4 visits|Subjective anxiety levels, reported by participants on visual analog scale (1-7) during Virtual Reality. 1 being no anxiety to 7 being high anxiety, on day 8 of each intervention arm (visit 2 and 4)|Subjective stress levels, reported by participants on visual analog scale (1-7) during Virtual Reality. 1 being no stress to 7 being high stress, on day 8 of each intervention arm (visit 2 and 4)
Secondary Outcome Measures: Gut microbiome, Assessed via stool samples after each intervention, on day 8 of each intervention arm (visit 2 and 4)|Daily food intake, Self-reported food intake recorded via FoodApp or handwritten food diary, 5 days of each intervention arm|Trait Anxiety Questionnaire, Trait version of State-Trait Anxiety Inventory (STAI; Grimm et al. 2009). High scores mean high trait anxiety., baseline before visit 1|State Anxiety Questionnaire, State version of State-Trait Anxiety Inventory (STAI; Grimm et al. 2009). High scores mean high state anxiety., on day 1 and 8 of each intervention arm (visit 1,2,3,4)|Interoception Questionnaire, Multidimensional Assessment of Interoceptive Awareness (MAIA; Bornemann et al. 2015). High scores mean high interoceptive ability., on day 8 of each intervention arm (visit 2 and 4)|Depression Questionnaire, Becks Depression Inventar (BDI; Kühner et al. 2007). High scores mean high depression scores, baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)|Mood Questionnaire, Positive and Negative Affect Schedule (PANAS; Janke et al. 2014). High score on positive scale mean high positive mood and high scores on negative scale mean high negative mood., on day 1 and 8 of each intervention arm (visit 1,2,3,4)|Inhibition Questionnaire, Behavioral Inhibition and Activation (BISBAS; Strobel et al. 2001). High scores on inhibition scale mean high inhibition and high scores on activation scale mean high activation., baseline (visit 1)|Impulsivity Questionnaire, Barratt Impulsiveness Scale (BIS; Barratt et al. 1965). High scores mean high impulsivity., baseline (visit 1)|Social Anxiety Questionnaire, Liebowitz Social Anxiety Scale (Heimberg et al. 1999). High scores mean high scoial anxiety, baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)|Flow Questionnaire, Flow state scale (FSS; Rheinberg et al. 2002) asked after Dual Task. High scores mean more flow experience during the dual task., on day 1 of each intervention arm (visit 1 and 3)|Emotional Eating Questionnaire, Salzburg Emotional Eating Scale (SEES; Meule et al. 2018), baseline (visit 1)|Stress Eating Questionnaire, Salzburg Stress Eating Scale (SSES; Meule et al. 2018), baseline (visit 1)|Dominance Questionnaire, Social Dominance and Aggressive Dominance Scale (Kalma et al. 1993), baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)|Autonomy Questionnaire, Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF; Heissel et al. 2019), on day 8 of each intervention arm (visit 2 and 4)|Personality Questionnaire, Big Five Inventory (BFI; John et al. 1991), baseline (visit 1)|Chronotype Questionnaire, Morningness-Eveningness Questionnaire (MEQ; Horne \& Östberg, 1976), baseline (visit 1)|Stress Questionnaire, Perceived Stress Questionnaire (PSQ; Fliege et al. 2001), baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)|Subjective anxiety levels, reported via FoodApp once per day, 5 days of each intervention arm|Subjective stress levels, reported via FoodApp once per day, 5 days of each intervention arm