Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06286943
Other study ID # S68124
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date May 2025

Study information

Verified date February 2024
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the present trial is to examine core executive functions (EFs) as a functional outcome of attenuating the cortisol response to acute laboratory stress through colonic delivery of an Short Chain Fatty Acids (SCFAs) mix (acetate, propionate, butyrate). A triple-blind randomized placebo-controlled parallel group trial will be conducted to compare the effects of SCFAs vs. placebo on core EFs (working memory [WM], cognitive flexibility [CF], response inhibition [RI]) under stress vs. no-stress conditions, after one week of SCFA vs. placebo treatment. First, the effects of SCFAs on stress-induced changes in core executive functions, with WM as the primary outcome, and CF and RI as secondary outcomes will be tested. Second, interindividual differences in microbiota composition (particularly abundance of SCFA-producers), saliva cortisol and serum SCFA levels will be explored to assess whether they are associated with interindividual differences in core EFs at baseline or following acute stress. Each participant will undergo 2 study visits: one will involve a stress condition and the other will involve a no-stress condition. Each study visit is preceded by a 1-week intervention or placebo period and separated by a 3-4 week washout period. To induce stress, participants will perform the Maastricht Acute Stress Task (MAST) or sham MAST as the control condition. To assess EF performance, three cognitive tasks will be performed 15 minutes after task offset: n-back task for WM; Stop Signal Task for RI; and Wisconsin Card Sorting Test for CF. Saliva samples will be collected before, during and after the (sham) MAST to assess the cortisol response. Blood samples will be collected throughout all study visits to quantify serum SCFAs, inflammatory markers and ACTH. Additionally, cardiovascular variables will be measured, and self-report questionnaires will be completed to evaluate autonomic response to the condition and subjective stress responses, respectively


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date May 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Short Chain Fatty Acids (SCFAs).
Colon-delivery capsules of SCFAs.
Placebo
Microcrystaline cellulose placebo capsules.
Other:
Maastricht Acute Stress Task
The Maastricht Acute Stress Task. This 15-minute stress-inducing task consists of a 5-minute preparation phase where instructions about the upcoming tasks are given, followed by a 10-minute acute stress phase where the hand immersion trial (HIT) in ice-cold water and mental arithmetic (MA) task is given interchangeably.
No-stress control task
The placebo version of the MAST follows the same structure of the MAST with none of the stress elements. It uses lukewarm water and simple arithmetic's.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven United States Department of Defense

Outcome

Type Measure Description Time frame Safety issue
Primary Working memory n-Back task Test day 1 and Test day 2 (Stress vs. No-stress conditions)
Secondary Cognitive Flexibility Wisconsin Card Sorting Task Test day 1 and Test day 2 (Stress vs. No-stress conditions)
Secondary Response Inhibition Stop Signal Task Test day 1 and Test day 2 (Stress vs. No-stress conditions)
See also
  Status Clinical Trial Phase
Completed NCT06038435 - The Effect of Cognitive Orientation Approach on Daily Occupational Performance With Autism Spectrum Disorder N/A
Completed NCT01365897 - Effectiveness of Modafinil in Improving Cognitive Performance of University Students Phase 4
Active, not recruiting NCT00747396 - The Bucharest Early Intervention Project N/A
Not yet recruiting NCT05513339 - Effect of Sleep Deprivation on Cognitive Function Among Cardiology Fellows
Completed NCT03003286 - Community Based Intervention for Children With ADHD and ASD N/A
Not yet recruiting NCT05468216 - Movement Integration in Primary Schools' Lessons N/A
Not yet recruiting NCT03946254 - Effect of Strength Training on Executive Functions in Elderly People With Mild Cognitive Impairment N/A
Completed NCT04082247 - Healthy Children 2021 Study in Childcare Centers N/A
Completed NCT03800030 - Effect of Cross Frequency tACS on Cognitive Control N/A
Recruiting NCT04989712 - MOReS Freestyle Libre Validation Study N/A
Active, not recruiting NCT05290584 - Influence of Preschool Children's Fundamental Movement Skills, Physical Activity, and Physical Fitness on Executive Function: A Prospective Observation Study
Recruiting NCT06175897 - Effects of STN DBS on Cognition and Brain Networks in PD Patients Analyzed Based on EEG and fNIRS N/A
Not yet recruiting NCT04103463 - Interactive Stepping Exercise on Memory N/A
Completed NCT03443323 - Organizational Skills Training N/A
Completed NCT04329663 - Effectiveness of the Indonesian Computer-based Game N/A
Not yet recruiting NCT01718405 - Genetic Polymorphism as Moderator of the Effect of an Acute Bout of Exercise on Cognitive Function N/A
Recruiting NCT06241300 - Executive Function and Parenting in Childhood N/A
Completed NCT05910632 - Eccentrically Reinforced Resistance Training vs. Traditional Resistance Training in Sedentary Older Women N/A
Completed NCT05462977 - Rhythmically Entrained Exercise in Community-Dwelling Older Adults N/A
Recruiting NCT06436209 - Cognitive Control & the Functional Organization of the Frontal Cortex N/A