Exogenous Ketones and Behavior
ExoKet
1 other identifier
interventional
45
1 country
1
Brief Summary
The study will examine the effect of exogenous ketone ester on behavior and metabolism using Virtual Reality and computerizes behavioral tasks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2024
CompletedStudy Start
First participant enrolled
July 18, 2024
CompletedFirst Posted
Study publicly available on registry
July 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2025
CompletedJuly 29, 2024
July 1, 2024
11 months
June 19, 2024
July 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (16)
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.
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)
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
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
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
on day 1 of each intervention arm (visit 1 and 3)
Levels of ketones (ß-Hydroxybutyrate)
Blood samples
baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Insulin
Blood samples
baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Ghrelin
Blood samples
baseline and + 90 minutes post drink-consumption on each of the 4 visits
Glucose Values
Continuous Glucose Monitoring through sensors applied to skin
every 15 Minutes from visit 1 to visit 2 and again from visit 3 to visit 4
Blood Glucose
Blood samples
baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Levels of cortisol
Blood samples
baseline, 15, 30, 60, and 90 minutes post drink-consumption on each of the 4 visits
Electrocardiogram (heart rate)
Electrophysiological recording
between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrocardiogram (heart rate variability)
Electrophysiological recordings
between 30 and 60 minutes post drink-consumption on each of the 4 visits
Electrodermal Activity
Electrophysiological recordings
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
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
on day 8 of each intervention arm (visit 2 and 4)
Secondary Outcomes (20)
Gut microbiome
on day 8 of each intervention arm (visit 2 and 4)
Daily food intake
5 days of each intervention arm
Trait Anxiety Questionnaire
baseline before visit 1
State Anxiety Questionnaire
on day 1 and 8 of each intervention arm (visit 1,2,3,4)
Interoception Questionnaire
on day 8 of each intervention arm (visit 2 and 4)
- +15 more secondary outcomes
Study Arms (2)
ketone ester
EXPERIMENTALParticipants consume a ketone ester 3x per day for 8 days.
Placebo containing dextrose
PLACEBO COMPARATORParticipants consume a placebo 3x per day for 8 days. The placebo is matched in calories and taste to the ketone ester.
Interventions
oral supplement calorie and taste matched to ketone supplement
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
German Institute of Human Nutrition
Potsdam, Brandenburg, 14558, Germany
Related Publications (3)
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.
PMID: 26744894BACKGROUNDGoette 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.
PMID: 25705012BACKGROUNDLiu 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.
PMID: 33722669BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
June 19, 2024
First Posted
July 23, 2024
Study Start
July 18, 2024
Primary Completion
June 23, 2025
Study Completion
June 23, 2025
Last Updated
July 29, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share