The impact of EcologicBarrier on neurocognitive measures of emotion & executive functioning

Completed

• Conditions: fundamenteel onderzoek (gezonde volwassenen); not applicable; 10027946

• Registration Number: NL-OMON43866
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• Females taking oral contraceptives (We will test participants in the weeks they take the pill, i.e. not in the stop week. This way, we will ensure that hormone levels are similar between the two test sessions)
• Age: 18-40 years old
• Dutch as a mother tongue
• Right-handed
• Willing to perform tasks in the MRI scanner, to come to the centre on two occasions, consuming Ecologic*Barrier (or a placebo) and willing to perform the written tests and questionnaires.
• BMI range between 18-25

Exclusion Criteria

• Previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history
• Current or recent (<3 months) regular medication use;
• Previous or current substance/alcohol dependence or abuse within the last 3 months
• Regular tobacco use (>5 cigarettes/day)
• Mild alcohol use (>5 glasses a week)
• Antibiotic use 3 months prior to the study
• Regular use of pre* and probiotics (and within 3 months prior to the study)
• Lactose Intolerance
• Vegan diet
• Diet changed drastically over the last 3 months, or planning/willing to change diet drastically in the near future
• MRI incompatibility (unremovable metal objects in body [plates, screws, serrefines, dental plates (pontics), metal splinters, piercings or medical plasters], active implant [e.g. pacemaker, neuro stimulator, insulin pump and/or hearing aid], head operation, epilepsy, claustrophobia).
• regular use of supplements 3 months prior or during the to the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The effect of the intervention will be tested in terms of BOLD signal measured<br /><br>with functional magnetic resonance imaging (fMRI) as well as response times on<br /><br>the cognitive tasks during fMRI.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondarily, the effects of the intervention will be tested in terms of<br /><br>paper-and-pencil neuropsychological tests and subjective measurements (i.e.<br /><br>self-report questionnaires and visual analog scales), physiological measures<br /><br>(blood pressure and heart rate), anthropomorphic measures (BMI and waist-hip<br /><br>ratio), cortisol and alpha-amylase (from saliva), and relative abundance of gut<br /><br>microbes (from stool sample). </p><br>