BehaviorExoKetNCT06515717
Exogenous Ketones and Behavior
A study testing ketone ester in people with Behavior, run by German Institute of Human Nutrition at 1 site in Germany.
Trial summary
The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior
- What is being tested?
- ketone ester
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2024to 23 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Soyoung Q Park, Prof. contact
Germany1 site, 1 recruiting
- Recruiting
German Institute of Human Nutrition
Potsdam, Brandenburg, 14558
Bianca Weigel, +49 33200 882724, DNN-Studie@dife.de
About this study
Official title: Exogenous Ketones and Behavior (ExoKet)
The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.
Read the 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.
- Conditions
- Behavior
- Being tested
- ketone ester, dextrose (placebo)
- Keywords
- ketones, human cognition, metabolism, anxiety, intervention
- Medical subject headings
- Behavior, Ketosis, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketone esterDietary supplement
oral supplement
dextrose (placebo)Dietary supplement
oral supplement calorie and taste matched to ketone supplement
| Study group | Role | What they receive |
|---|---|---|
| ketone ester | Experimental | Participants consume a ketone ester 3x per day for 8 days. Receives: Dietary Supplement: ketone ester |
| Placebo containing dextrose | Placebo comparator | Participants consume a placebo 3x per day for 8 days. The placebo is matched in calories and taste to the ketone ester. Receives: Dietary Supplement: dextrose (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: on day 1 of each intervention arm (visit 1 and 3)
Levels of ketones (ß-Hydroxybutyrate)
Blood samples
Measured: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Insulin
Blood samples
Measured: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Ghrelin
Blood samples
Measured: baseline and + 90 minutes post drink-consumption on each of the 4 visits
Glucose Values
Continuous Glucose Monitoring through sensors applied to skin
Measured: every 15 Minutes from visit 1 to visit 2 and again from visit 3 to visit 4
Blood Glucose
Blood samples
Measured: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Levels of cortisol
Blood samples
Measured: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Electrocardiogram (heart rate)
Electrophysiological recording
Measured: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrocardiogram (heart rate variability)
Electrophysiological recordings
Measured: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrodermal Activity
Electrophysiological recordings
Measured: 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
Measured: 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
Measured: on day 8 of each intervention arm (visit 2 and 4)
Secondary outcomes (20)
Gut microbiome
Assessed via stool samples after each intervention
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: baseline (visit 1)
Impulsivity Questionnaire
Barratt Impulsiveness Scale (BIS; Barratt et al. 1965). High scores mean high impulsivity.
Measured: baseline (visit 1)
Social Anxiety Questionnaire
Liebowitz Social Anxiety Scale (Heimberg et al. 1999). High scores mean high scoial anxiety
Measured: 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.
Measured: on day 1 of each intervention arm (visit 1 and 3)
Emotional Eating Questionnaire
Salzburg Emotional Eating Scale (SEES; Meule et al. 2018)
Measured: baseline (visit 1)
Stress Eating Questionnaire
Salzburg Stress Eating Scale (SSES; Meule et al. 2018)
Measured: baseline (visit 1)
Dominance Questionnaire
Social Dominance and Aggressive Dominance Scale (Kalma et al. 1993)
Measured: 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)
Measured: on day 8 of each intervention arm (visit 2 and 4)
Personality Questionnaire
Big Five Inventory (BFI; John et al. 1991)
Measured: baseline (visit 1)
Chronotype Questionnaire
Morningness-Eveningness Questionnaire (MEQ; Horne \& Östberg, 1976)
Measured: baseline (visit 1)
Stress Questionnaire
Perceived Stress Questionnaire (PSQ; Fliege et al. 2001)
Measured: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
Subjective anxiety levels
reported via FoodApp once per day
Measured: 5 days of each intervention arm
Subjective stress levels
reported via FoodApp once per day
Measured: 5 days of each intervention arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start18 Jul 2024 (estimated)
- Primary completion23 Jun 2025 (estimated)
- Study completion23 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Institute of Human Nutrition
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Soyoung Q Park, German Institute of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515717
- Sponsor's protocol ID
- ExoKet
- Acronym
- ExoKet
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 26744894Goette 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.
PubMed 25705012Liu 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.
PubMed 33722669
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exogenous Ketones and Behavior (ExoKet)
- ClinicalTrials.gov ID
- NCT06515717
- Acronym / sponsor ID
- ExoKet / ExoKet
- Conditions
- Behavior
- Keywords
- ketones, human cognition, metabolism, anxiety, intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- German Institute of Human NutritionUniversity, hospital or other
- Study start
- 18 Jul 2024 (estimated)
- Primary completion
- 23 Jun 2025 (estimated)
- Study completion
- 23 Jun 2025 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketone ester | Experimental | Dietary Supplement: ketone esterParticipants consume a ketone ester 3x per day for 8 days. |
| Placebo containing dextrose | Placebo comparator | Dietary Supplement: dextrose (placebo)Participants consume a placebo 3x per day for 8 days. The placebo is matched in calories and taste to the ketone ester. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ketone esteroral supplement | Dietary supplement | ketone ester |
| dextrose (placebo)oral supplement calorie and taste matched to ketone supplement | Dietary supplement | Placebo containing dextrose |
Primary outcome
Anxiety behavior in Virtual Reality
Time frame: 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.
Risk propensity on a decision-making task
Time frame: 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)
Competitive confidence in a competition task
Time frame: on day 8 of each intervention arm (visit 2 and 4)
based on a task paradigm by Goette et al., 2015
Delay Discounting behavior in a computerized task
Time frame: on day 1 of each intervention arm (visit 1 and 3)
based on a task paradigm by Eisenstein et al. 2015
Performance in Dual Task
Time frame: on day 1 of each intervention arm (visit 1 and 3)
based on a task paradigm by Szameitat et al., 2002
Levels of ketones (ß-Hydroxybutyrate)
Time frame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Insulin
Time frame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Ghrelin
Time frame: baseline and + 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Glucose Values
Time frame: 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
Blood Glucose
Time frame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Levels of cortisol
Time frame: baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Blood samples
Electrocardiogram (heart rate)
Time frame: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrophysiological recording
Electrocardiogram (heart rate variability)
Time frame: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrophysiological recordings
Electrodermal Activity
Time frame: between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrophysiological recordings
Subjective anxiety levels
Time frame: 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
Subjective stress levels
Time frame: 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
20 secondary outcomes
Gut microbiome
Time frame: on day 8 of each intervention arm (visit 2 and 4)
Daily food intake
Time frame: 5 days of each intervention arm
Trait Anxiety Questionnaire
Time frame: baseline before visit 1
State Anxiety Questionnaire
Time frame: on day 1 and 8 of each intervention arm (visit 1,2,3,4)
Interoception Questionnaire
Time frame: on day 8 of each intervention arm (visit 2 and 4)
Depression Questionnaire
Time frame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
Mood Questionnaire
Time frame: on day 1 and 8 of each intervention arm (visit 1,2,3,4)
Inhibition Questionnaire
Time frame: baseline (visit 1)
Impulsivity Questionnaire
Time frame: baseline (visit 1)
Social Anxiety Questionnaire
Time frame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
Flow Questionnaire
Time frame: on day 1 of each intervention arm (visit 1 and 3)
Emotional Eating Questionnaire
Time frame: baseline (visit 1)
Stress Eating Questionnaire
Time frame: baseline (visit 1)
Dominance Questionnaire
Time frame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
Autonomy Questionnaire
Time frame: on day 8 of each intervention arm (visit 2 and 4)
Personality Questionnaire
Time frame: baseline (visit 1)
Chronotype Questionnaire
Time frame: baseline (visit 1)
Stress Questionnaire
Time frame: baseline, and on day 8 of each intervention arm (visit 1, 2, and 4)
Subjective anxiety levels
Time frame: 5 days of each intervention arm
Subjective stress levels
Time frame: 5 days of each intervention arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Background: PubMed 26744894Eisenstein 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.
- Background: PubMed 25705012Goette 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.
- Background: PubMed 33722669Liu 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soyoung Q Park, Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ketone ester in people with Behavior, run by German Institute of Human Nutrition at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beatrix Keweloh (+49 33200 882518, Beatrix.Keweloh@dife.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety behavior in Virtual Reality (time frame: on day 8 of each intervention arm (visit 2 and 4)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06515717, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.