Nutritional intervention to prevent stress-related gut issues
A Nutritional Intervention to Prevent Stress Induced Intestinal Hyper-Permeability
This study is testing if a special diet can help people with stress-related gut problems by seeing if certain supplements improve gut health during stressful situations.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06089811 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 18 to 40 with a BMI between 18.5 and 25.
Not a fit: Patients outside the specified age range, with a BMI outside the normal range, or those with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help improve gut health and reduce stress-related intestinal issues in patients.
How similar studies have performed: Previous studies have indicated that nutritional interventions can positively influence gut health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Leuven, Vlaams-Brabant
- KU Leuven/ UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Study coordinator: Danique La Torre, MSc
- Email: danique.latorre@kuleuven.be
- Phone: +3216373499
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.