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ID
Source
Brief title
Health condition
Emotion processing and executive functioning in a healthy population.
Probiotics, Nervous System, Stress and Emotions
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neurocognitive measures of emotion and executive functioning.
Secondary outcome
Neuropsychological (questionnaires), physiological, and fecal measures.
Background summary
Changes in microbiota-gut- brain axis have been linked to alterations in emotional-cognitive behavior
consistent with some anxiety and depressive symptoms. Recently, a growing body of animal studies
proves evidences for effects of probiotics on gut microblome composition and functions. Accordingly,
the present fMRI study aims to define the effects of probiotics supplementation on emotion, executive
functioning and brain activity in a double-blind, placebo controlled design. Short term effects will be
investigated after four weeks of supplementation with probiotics from the baseline in a Healthy human
population.
Study objective
The aim of the present study is to investigate the effects of probiotic supplementation with Ecologic®Barrier on emotion processing and executive functioning in human subjects by using fMRI.
Study design
First scanning session before starting probiotic supplementation (T0) and second scanning session within a week after the end of the intervention (T1).
Intervention
28 days of 2g multi-species probiotic (Ecologic-®Barrier)/Placebo supplementation (1x daily)
Inclusion criteria
Inclusion criteria:
- Females taking hormonal contraceptives;
- Age: 18-40 years old;
- Dutch as a mother tongue or fluent in Dutch;
- Right-handed;
- BMI range between 18–25;
Exclusion criteria
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);
- Moderate alcohol use (>10 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).
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5693 |
| NTR-old | NTR5845 |
| CCMO | NL55406.091.15 |
| OMON | NL-OMON43866 |