Exogenous Ketones and Behavior

German Institute of Human Nutrition45 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Behavior

Interventions

ketone esterDIETARY_SUPPLEMENT

oral supplement

dextrose (placebo)DIETARY_SUPPLEMENT

oral supplement calorie and taste matched to ketone supplement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

German Institute of Human Nutrition

Potsdam, Brandenburg, Germany

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Beatrix Keweloh

CONTACT

+49 33200 882518 Beatrix.Keweloh@dife.de

Soyoung Q Park, Prof.

CONTACT

Soyoung.Park@dife.de

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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