Exogenous Ketones and Behavior
- Conditions
- Behavior
- Interventions
- Dietary Supplement: ketone esterDietary Supplement: dextrose (placebo)
- Registration Number
- NCT06515717
- Lead Sponsor
- German Institute of Human Nutrition
- Brief Summary
The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description ketone ester ketone ester Participants consume a ketone ester 3x per day for 8 days. Placebo containing dextrose dextrose (placebo) Participants consume a placebo 3x per day for 8 days. The placebo is matched in calories and taste to the ketone ester.
- Primary Outcome Measures
Name Time Method Levels of ketones (ß-Hydroxybutyrate) baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits Blood samples
Glucose Values every 15 Minutes from visit 1 to visit 2 and again from visit 3 to visit 4 Continuous Glucose Monitoring through sensors applied to skin
Subjective anxiety levels on day 8 of each intervention arm (visit 2 and 4) reported by participants on visual analog scale (1-7) during Virtual Reality. 1 being no anxiety to 7 being high anxiety
Competitive confidence in a competition task on day 8 of each intervention arm (visit 2 and 4) based on a task paradigm by Goette et al., 2015
Blood Glucose baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits Blood samples
Risk propensity on a decision-making task on day 8 of each intervention arm (visit 2 and 4) The choice (accept/reject) between a risk/gamble or safe option, based on a task paradigm by Liu et al. (2021)
Performance in Dual Task on day 1 of each intervention arm (visit 1 and 3) based on a task paradigm by Szameitat et al., 2002
Electrocardiogram (heart rate) between 30 and 60 minutes post drink-consumption on each of the 4 visits Electrophysiological recording
Anxiety behavior in Virtual Reality on day 8 of each intervention arm (visit 2 and 4) 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.
Delay Discounting behavior in a computerized task on day 1 of each intervention arm (visit 1 and 3) based on a task paradigm by Eisenstein et al. 2015
Insulin baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits Blood samples
Ghrelin baseline and + 90 minutes post drink-consumption on each of the 4 visits Blood samples
Electrocardiogram (heart rate variability) between 30 and 60 minutes post drink-consumption on each of the 4 visits Electrophysiological recordings
Subjective stress levels on day 8 of each intervention arm (visit 2 and 4) reported by participants on visual analog scale (1-7) during Virtual Reality. 1 being no stress to 7 being high stress
Levels of cortisol baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits Blood samples
Electrodermal Activity between 30 and 60 minutes post drink-consumption on each of the 4 visits Electrophysiological recordings
- Secondary Outcome Measures
Name Time Method Stress Eating Questionnaire baseline (visit 1) Salzburg Stress Eating Scale (SSES; Meule et al. 2018)
Trait Anxiety Questionnaire baseline before visit 1 Trait version of State-Trait Anxiety Inventory (STAI; Grimm et al. 2009). High scores mean high trait anxiety.
State Anxiety Questionnaire on day 1 and 8 of each intervention arm (visit 1,2,3,4) State version of State-Trait Anxiety Inventory (STAI; Grimm et al. 2009). High scores mean high state anxiety.
Personality Questionnaire baseline (visit 1) Big Five Inventory (BFI; John et al. 1991)
Gut microbiome on day 8 of each intervention arm (visit 2 and 4) Assessed via stool samples after each intervention
Depression Questionnaire baseline, and on day 8 of each intervention arm (visit 1, 2, and 4) Becks Depression Inventar (BDI; Kühner et al. 2007). High scores mean high depression scores
Social Anxiety Questionnaire baseline, and on day 8 of each intervention arm (visit 1, 2, and 4) Liebowitz Social Anxiety Scale (Heimberg et al. 1999). High scores mean high scoial anxiety
Flow Questionnaire on day 1 of each intervention arm (visit 1 and 3) Flow state scale (FSS; Rheinberg et al. 2002) asked after Dual Task. High scores mean more flow experience during the dual task.
Dominance Questionnaire baseline, and on day 8 of each intervention arm (visit 1, 2, and 4) Social Dominance and Aggressive Dominance Scale (Kalma et al. 1993)
Stress Questionnaire baseline, and on day 8 of each intervention arm (visit 1, 2, and 4) Perceived Stress Questionnaire (PSQ; Fliege et al. 2001)
Subjective anxiety levels 5 days of each intervention arm reported via FoodApp once per day
Daily food intake 5 days of each intervention arm Self-reported food intake recorded via FoodApp or handwritten food diary
Interoception Questionnaire on day 8 of each intervention arm (visit 2 and 4) Multidimensional Assessment of Interoceptive Awareness (MAIA; Bornemann et al. 2015). High scores mean high interoceptive ability.
Mood Questionnaire on day 1 and 8 of each intervention arm (visit 1,2,3,4) 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.
Impulsivity Questionnaire baseline (visit 1) Barratt Impulsiveness Scale (BIS; Barratt et al. 1965). High scores mean high impulsivity.
Emotional Eating Questionnaire baseline (visit 1) Salzburg Emotional Eating Scale (SEES; Meule et al. 2018)
Autonomy Questionnaire on day 8 of each intervention arm (visit 2 and 4) Basic Psychological Need Satisfaction and Frustration Scale (BPNSNF; Heissel et al. 2019)
Inhibition Questionnaire baseline (visit 1) 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.
Subjective stress levels 5 days of each intervention arm reported via FoodApp once per day
Chronotype Questionnaire baseline (visit 1) Morningness-Eveningness Questionnaire (MEQ; Horne \& Östberg, 1976)
Trial Locations
- Locations (1)
German Institute of Human Nutrition
🇩🇪Potsdam, Brandenburg, Germany