Correction: Insulin, Central Dopamine D2 Receptors, and Monetary Reward Discounting in Obesity.
Sarah A Eisenstein, Danuta M Gredysa, Jo Ann Antenor-Dorsey...
https://pubmed.ncbi.nlm.nih.gov/26744894Actively Recruiting
Phase Not Applicable
Age: 18Years - 45Years
All Genders
Healthy Volunteers
ID06515717
Exogenous Ketones and Behavior (ExoKet)
Led by German Institute of Human Nutrition · Updated on 2024-07-29
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study how an oral ketone ester supplement affects behavior, thinking, and metabolism in healthy adults aged 18 to 45. The trial uses a randomized, crossover design where each participant will consume both the ketone ester and a calorie- and taste-matched placebo to compare effects. The study is led by the German Institute of Human Nutrition and focuses on behavioral and metabolic changes over a short period. Participants will take the ketone ester or placebo three times daily for eight days during each intervention phase. There are two main phases: one with the ketone ester supplement and one with the placebo, with four lab visits total. Visits 1 and 3 mark the start of each phase, while visits 2 and 4 mark the end. During these visits, participants will complete behavioral tasks, questionnaires, and blood tests. Throughout the study, participants will track their food intake using an app and collect stool samples. Researchers will measure various outcomes including anxiety and risk behavior in virtual reality, decision-making, metabolic markers like ketones and glucose, heart rate, and stress levels. Questionnaires will assess mood, anxiety, personality, and eating behaviors. The total participation spans about two weeks, covering both intervention periods and assessments.
CONDITIONS
Brief Title
Exogenous Ketones and Behavior
Who Can Participate
Age: 18Years - 45Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Consent to participate
- Fluent in German
- Physically healthy with no regular medication
- No drug use for at least 1 week prior to the study
- Body mass index between 18 and 31 kg/m2
- Aged between 18 and 45 years
- Able to participate in all study visits and procedures
You will not qualify if you...
- History or current illness of brain or mental health conditions including eating or personality disorders, substance dependence, neurological disorders (except occasional headache), depression, or anxiety disorder
- Heart or blood circulation disorders
- Gastro-intestinal or endocrine disorders
- Liver or kidney disorders
- Electrolyte imbalances
- Serious past or present medical conditions such as metabolic syndrome, diabetes, or cancer
- Pregnancy
- Extreme athletes engaging in more than 2 hours per day of intense exercise
- Menopause (post-menopause is allowed)
- Following a ketogenic diet, ketogenic supplement intake, intermittent fasting, or calorie restricted diet within 4 weeks before study
- Fear of blood draws
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Two 8-day intervention periods with a crossover design
Participants consume either the ketone ester supplement or the calorie- and taste-matched placebo three times per day for 8 days, completing behavioral tasks, questionnaires, and blood tests during four lab visits across the study.
4 lab visits (in-person) across both interventions
Trial Site Locations
Total: 1 location
1
German Institute of Human Nutrition
Potsdam, Brandenburg, Germany, 14558
Actively Recruiting
Loading map...
Research Team
B
Beatrix Keweloh
S
Soyoung Q Park, Prof.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Stress pulls us apart: anxiety leads to differences in competitive confidence under stress.
Lorenz Goette, Samuel Bendahan, John Thoresen...
https://pubmed.ncbi.nlm.nih.gov/25705012Eating to dare - Nutrition impacts human risky decision and related brain function.
Lu Liu, Sergio Oroz Artigas, Anja Ulrich...
https://pubmed.ncbi.nlm.nih.gov/33722669