Status:
COMPLETED
Effects of Butyrate on Affective Processes
Lead Sponsor:
KU Leuven
Conditions:
Emotions
Stress
Eligibility:
MALE
20-40 years
Phase:
NA
Brief Summary
The effects of butyrate on psychobiological processes are examined in a sample of healthy volunteers.
Detailed Description
The study is an interventional triple-blind, placebo-controlled, parallel group design with 2 arms (placebo, butyrate). Healthy male participants adhere to a low-fiber diet for the duration of the stu...
Eligibility Criteria
Inclusion
- Male participants
- Age range 20-40 years
- BMI range 18.5-25
- Dutch or English as native-language
Exclusion
- previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history
- current or recent regular medication use
- previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
- one or more diagnoses based on the mini-international neuropsychiatric interview
- smoking
- night-shift work
- adherence to vegan or vegetarian diets
- use of pre- or probiotics within one month preceding the study
- use of antibiotics within 3 months preceding the study
- previous experience with one of the tasks used in the study
Key Trial Info
Start Date :
February 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2022
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04722549
Start Date
February 8 2021
End Date
December 11 2022
Last Update
January 4 2023
Active Locations (1)
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1
UZ Leuven/Stresslab
Leuven, I Am Not in the U.S. Or Canada, Belgium, 3000