Status:
UNKNOWN
A Nutritional Intervention to Prevent Stress Induced Intestinal Hyper-Permeability
Lead Sponsor:
KU Leuven
Conditions:
Stress, Psychological
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The interaction between the gut microbiome, the intestinal barrier, and the host plays an important role in human health. The integrity of the intestinal barrier is essential to protect against transl...
Eligibility Criteria
Inclusion
- Age 18 till 40 years (both included)
- BMI range: 18.5 - 25 kg/m²
- Females: Use of contraceptives, and have to use the current contraceptive method for at least 4 months. A regular menstrual cycle (between 25 and 35 days; if not using oral contraceptives)
- Subject is willing to not consume caffeine, or alcohol, to refrain from smoking, and not to engage in heavy physical exercise three days before the test days, as well as to not consume dairy products and chewing gum the day before and the day of the test days
- Subject is willing to not take any non-steroidal anti-inflammatory drugs (NSAIDs) two weeks before the test days (see Appendix G for an overview of NSAIDs)
- Subject, upon briefing of the content of the present study, fully understands and agrees to its objective and has given written (dated and signed) informed consent form to take part in the study
- Subject is able to communicate well with the investigator and follow instructions given by the investigator
Exclusion
- Subject has a previous or current neurological, psychiatric, gastrointestinal, or endocrine disorder, or other relevant medical history
- Subject has one or more diagnoses based on the MINI international neuropsychiatric interview
- Subject has one or more diagnoses based on the ROME-IV for GI disorders
- Subject uses regular medication (i.e., anti-allergy medication, PPI's, and medication that can affect gut motility), currently or recently (in the last 2 weeks) (except for oral contraceptives)
- Subject has used recreational drugs in the past 6 months
- Subject consumes regularly (\>1/week) more than 3 units of alcohol per day
- Subjects smokes \>7 cigarettes per week
- Subject has to work in night-shifts
- Subject is pregnant or lactating
- Subject has previous experience with the stress test used in the study
- Subject has taken prebiotics or probiotics in the last month
- Subject has taken antibiotics in the last 3 months
- Subjects consumes \>25g of fiber per day in their habitual diet
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06089811
Start Date
October 10 2023
End Date
July 1 2024
Last Update
October 18 2023
Active Locations (1)
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1
KU Leuven/ UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000