A Nutritional Intervention to Prevent Stress Induced Intestinal Hyper-Permeability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-07-01

Brief Summary

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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 translocation of food antigens and immunostimulatory microbial metabolites from the gut lumen. Accumulating studies show that stress may negatively affect the intestinal barrier function. In a previous study, the investigators developed the Leuven Prolonged Acute Stress Test (L-PAST), which combines physical (cold water), mental (arithmetic), and social (negative feedback) aspects of stress for a prolonged (2h) time. In the current study the investigators would like, as a first aim, to investigate whether the L-PAST 1) increases intestinal permeability compared to baseline intestinal permeability, and 2) whether a nutritional intervention can improve baseline intestinal permeability as well as intestinal permeability after exposure to the L-PAST in both healthy females and men. As a second aim of the present study, the investigators would like to investigate whether prebiotics and/or L-tryptophan can attenuate the cortisol response to stress. Lastly, as acute psychosocial stress impairs cognitive functions, the investigators would like as a third aim to investigate whether prebiotics and/or L-tryptophan supplementation may prevent these impairments.

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Detailed Description

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Conditions

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Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The present study is a parallel group randomized controlled trial (RCT) aiming to investigate whether two nutritional interventions (prebiotics and L-tryptophan) can improve intestinal barrier function, attenuate the stress response, affect cognitive processes, and prevent stress-induced hyperpermeability. Participants will perform 2 study visits of 3h each and with 28 days in between, in which participants will be subjected to the L-PAST. During the L-PAST, 3 cognitive tasks will be administered. Moreover, participants will be asked to take a basal intestinal permeability test at home 2 days before the test days.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Participants, investigators, and personnel involved in data analyses are blinded to the intervention. Unblinding occurs after all data has been collected AND analysed.

Study Groups

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