Nutritional intervention to prevent stress-related gut issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of stress on intestinal permeability and whether a nutritional intervention can mitigate these effects. Using the Leuven Prolonged Acute Stress Test (L-PAST), which combines physical, mental, and social stressors, the researchers will assess changes in gut barrier function. Participants will receive either a prebiotic, L-Tryptophan, or a placebo to evaluate their effectiveness in improving intestinal permeability before and after stress exposure. The study aims to provide insights into the relationship between nutrition, stress, and gut health.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• KU Leuven/ UZ Leuven
  Leuven, Vlaams-Brabant, Belgium Recruiting

Study contacts

• Study coordinator: Danique La Torre, MSc
• Email: danique.latorre@kuleuven.be
• Phone: +3216373499

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.