An interventional study of ketone ester and dextrose (placebo) in Behavior, sponsored by German Institute of Human Nutrition. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-29.
Sponsored by German Institute of Human Nutrition · Not applicable, Interventional, and Basic science
The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.
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.
Exclusion Criteria:
Participants consume a ketone ester 3x per day for 8 days.
Dietary Supplement: ketone ester
Participants consume a placebo 3x per day for 8 days. The placebo is matched in calories and taste to the ketone ester.
Dietary Supplement: dextrose (placebo)
oral supplement
oral supplement calorie and taste matched to ketone supplement
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)
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)
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)
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)
Performance in Dual Task
based on a task paradigm by Szameitat et al., 2002
Time frame: on day 1 of each intervention arm (visit 1 and 3)
Levels of ketones (ß-Hydroxybutyrate)
Blood samples
Time frame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Insulin
Blood samples
Time frame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Ghrelin
Blood samples
Time frame: baseline and + 90 minutes post drink-consumption on each of the 4 visits
Glucose Values
Continuous Glucose Monitoring through sensors applied to skin
Time frame: every 15 Minutes from visit 1 to visit 2 and again from visit 3 to visit 4
Blood Glucose
Blood samples
Time frame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Levels of cortisol
Blood samples
Time frame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Electrocardiogram (heart rate)
Electrophysiological recording
Time frame: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrocardiogram (heart rate variability)
Electrophysiological recordings
Time frame: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrodermal Activity
Electrophysiological recordings
Time frame: 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
Time frame: 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
Time frame: on day 8 of each intervention arm (visit 2 and 4)
Gut microbiome
Assessed via stool samples after each intervention
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: baseline (visit 1)
Impulsivity Questionnaire
Barratt Impulsiveness Scale (BIS; Barratt et al. 1965). High scores mean high impulsivity.
Time frame: baseline (visit 1)
Social Anxiety Questionnaire
Liebowitz Social Anxiety Scale (Heimberg et al. 1999). High scores mean high scoial anxiety
Time frame: 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.
Time frame: on day 1 of each intervention arm (visit 1 and 3)
Emotional Eating Questionnaire
Salzburg Emotional Eating Scale (SEES; Meule et al. 2018)
Time frame: baseline (visit 1)
Stress Eating Questionnaire
Salzburg Stress Eating Scale (SSES; Meule et al. 2018)
Time frame: baseline (visit 1)
Dominance Questionnaire
Social Dominance and Aggressive Dominance Scale (Kalma et al. 1993)
Time frame: 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)
Time frame: on day 8 of each intervention arm (visit 2 and 4)
Personality Questionnaire
Big Five Inventory (BFI; John et al. 1991)
Time frame: baseline (visit 1)
Chronotype Questionnaire
Morningness-Eveningness Questionnaire (MEQ; Horne \& Östberg, 1976)
Time frame: baseline (visit 1)
Stress Questionnaire
Perceived Stress Questionnaire (PSQ; Fliege et al. 2001)
Time frame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
Subjective anxiety levels
reported via FoodApp once per day
Time frame: 5 days of each intervention arm
Subjective stress levels
reported via FoodApp once per day
Time frame: 5 days of each intervention arm
Plan to share: Yes
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German Institute of Human Nutrition