Clinical trial NCT06515717: Exogenous Ketones and Behavior
Official title: Exogenous Ketones and Behavior (ExoKet)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavior
Keywords: ketones
human cognition
metabolism
anxiety
intervention
Lead sponsor: German Institute of Human Nutrition
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety behavior in Virtual Reality
timeFrame: on day 8 of each intervention arm (visit 2 and 4)
measure: Risk propensity on a decision-making task
timeFrame: on day 8 of each intervention arm (visit 2 and 4)
measure: Competitive confidence in a competition task
timeFrame: on day 8 of each intervention arm (visit 2 and 4)
measure: Delay Discounting behavior in a computerized task
timeFrame: on day 1 of each intervention arm (visit 1 and 3)
measure: Performance in Dual Task
timeFrame: on day 1 of each intervention arm (visit 1 and 3)
measure: Levels of ketones (ß-Hydroxybutyrate)
timeFrame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
measure: Insulin
timeFrame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
measure: Ghrelin
timeFrame: baseline and + 90 minutes post drink-consumption on each of the 4 visits
measure: Glucose Values
timeFrame: every 15 Minutes from visit 1 to visit 2 and again from visit 3 to visit 4
measure: Blood Glucose
timeFrame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
measure: Levels of cortisol
timeFrame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
measure: Electrocardiogram (heart rate)
timeFrame: between 30 and 60 minutes post drink-consumption on each of the 4 visits
measure: Electrocardiogram (heart rate variability)
timeFrame: between 30 and 60 minutes post drink-consumption on each of the 4 visits
measure: Electrodermal Activity
timeFrame: between 30 and 60 minutes post drink-consumption on each of the 4 visits
measure: Subjective anxiety levels
timeFrame: on day 8 of each intervention arm (visit 2 and 4)
measure: Subjective stress levels
timeFrame: on day 8 of each intervention arm (visit 2 and 4)
Secondary outcomes:
measure: Gut microbiome
timeFrame: on day 8 of each intervention arm (visit 2 and 4)
measure: Daily food intake
timeFrame: 5 days of each intervention arm
measure: Trait Anxiety Questionnaire
timeFrame: baseline before visit 1
measure: State Anxiety Questionnaire
timeFrame: on day 1 and 8 of each intervention arm (visit 1,2,3,4)
measure: Interoception Questionnaire
timeFrame: on day 8 of each intervention arm (visit 2 and 4)
measure: Depression Questionnaire
timeFrame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
measure: Mood Questionnaire
timeFrame: on day 1 and 8 of each intervention arm (visit 1,2,3,4)
measure: Inhibition Questionnaire
timeFrame: baseline (visit 1)
measure: Impulsivity Questionnaire
timeFrame: baseline (visit 1)
measure: Social Anxiety Questionnaire
timeFrame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
measure: Flow Questionnaire
timeFrame: on day 1 of each intervention arm (visit 1 and 3)
measure: Emotional Eating Questionnaire
timeFrame: baseline (visit 1)
measure: Stress Eating Questionnaire
timeFrame: baseline (visit 1)
measure: Dominance Questionnaire
timeFrame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
measure: Autonomy Questionnaire
timeFrame: on day 8 of each intervention arm (visit 2 and 4)
measure: Personality Questionnaire
timeFrame: baseline (visit 1)
measure: Chronotype Questionnaire
timeFrame: baseline (visit 1)
measure: Stress Questionnaire
timeFrame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
measure: Subjective anxiety levels
timeFrame: 5 days of each intervention arm
measure: Subjective stress levels
timeFrame: 5 days of each intervention arm
Other outcomes:
Locations:
city: Potsdam
country: Germany
facility: German Institute of Human Nutrition
state: Brandenburg
Study officials:
References:
citation: Eisenstein SA, Gredysa DM, Antenor-Dorsey JA, Green L, Arbelaez AM, Koller JM, Black KJ, Perlmutter JS, Moerlein SM, Hershey T. Correction: Insulin, Central Dopamine D2 Receptors, and Monetary Reward Discounting in Obesity. PLoS One. 2016 Jan 8;11(1):e0147063. doi: 10.1371/journal.pone.0147063. eCollection 2016. No abstract available.
citation: Goette L, Bendahan S, Thoresen J, Hollis F, Sandi C. Stress pulls us apart: anxiety leads to differences in competitive confidence under stress. Psychoneuroendocrinology. 2015 Apr;54:115-23. doi: 10.1016/j.psyneuen.2015.01.019. Epub 2015 Feb 19.
citation: Liu L, Artigas SO, Ulrich A, Tardu J, Mohr PNC, Wilms B, Koletzko B, Schmid SM, Park SQ. Eating to dare - Nutrition impacts human risky decision and related brain function. Neuroimage. 2021 Jun;233:117951. doi: 10.1016/j.neuroimage.2021.117951. Epub 2021 Mar 12.