The Effects of Short-Chain Fatty Acids in Psychosocial Stress-Induced Impairment on Core Executive Functions

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a mix of short-chain fatty acids (SCFAs) might help people cope better with stress and improve certain thinking skills, known as executive functions. These executive functions include working memory (the ability to hold and manipulate information), cognitive flexibility (the ability to switch between tasks or thoughts), and response inhibition (the ability to control impulses). The trial aims to see if taking SCFAs can reduce the body's stress response, measured through cortisol levels, and improve these thinking skills during both stressful and relaxed situations.

To participate in this study, you need to be a healthy male between the ages of 20 and 40, with a body mass index (BMI) between 18.5 and 25. You should be proficient in English or Dutch and have no history of psychological or gastrointestinal problems. If you join, you will take part in two study visits: one where you will experience a stress-inducing task and another where you will not. After a week of either taking the SCFAs or a placebo (a non-active substance), you will perform different cognitive tasks to evaluate your executive functions. Throughout the study, some samples of saliva and blood will be taken to measure your body’s response to stress and the effects of SCFAs. This trial is not yet recruiting participants, but it could be an opportunity to contribute to understanding how diet affects our mental resilience.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• • Proficiency in English and/or Dutch
• • Healthy with no intestinal and/or psychological complaints
• • Access to a -18°C freezer (i.e. ordinary household freezer)
• • Male participants
• • Age 20-40 years
• • BMI 18.5-25 kg/m2
• Exclusion Criteria:
• • Participant has a history of previous or current neurological, psychiatric, gastrointestinal or endocrine disorder
• • Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
• • Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the study
• • Participation in an interventional Trial with an investigational medicinal product (IMP) or device
• • Current or recent (over the past month) medication use as a (prescribed) medical treatment. This does not include isolated intakes of 'over the counter' medication (e.g. ibuprofen, paracetamol).
• • Use of antibiotics within three months preceding the study.
• • Current or recent (1-month) infection (e.g. common cold, influenza, COVID-19, etc.)
• • Recent (1-month) vaccination (e.g. flu shot, SARS-COV-2 vaccine, etc)
• • Previous or current substance/alcohol dependence or abuse (\>2 units per day or 14 units per week).
• • One or more diagnoses based on the Mini International Neuropsychiatric Interview.
• • One or more diagnoses based on ROME-IV for gastrointestinal disorders.
• • Smoking.
• • Night-shift work.
• • Adherence to special diets (e.g. vegan, vegetarian, weight-loss, lactose-free, gluten-free, etc.).
• • Use of pre- or probiotics within one month preceding the study.
• • Previous experience with or knowledge of any of the tasks used in the study (not including questionnaires).