To investigate the impact of the multispecies probiotic product Ecologic*Barrier on neurocognitive measures of emotion and executive functioning.
ID
Source
Brief title
Condition
- Other condition
- Mood disorders and disturbances NEC
Synonym
Health condition
fundamenteel onderzoek (gezonde volwassenen)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The effect of the intervention will be tested in terms of BOLD signal measured
with functional magnetic resonance imaging (fMRI) as well as response times on
the cognitive tasks during fMRI.
Secondary outcome
Secondarily, the effects of the intervention will be tested in terms of
paper-and-pencil neuropsychological tests and subjective measurements (i.e.
self-report questionnaires and visual analog scales), physiological measures
(blood pressure and heart rate), anthropomorphic measures (BMI and waist-hip
ratio), cortisol and alpha-amylase (from saliva), and relative abundance of gut
microbes (from stool sample).
Background summary
Different probiotic products have been shown to be effective in different
animal models of depression and anxiety. Recent human studies show that
consumption of probiotics modulated brain activity, regulated cognitive
reactivity, alleviated psychological distress and altered urinary cortisol
levels in healthy volunteers. It becomes increasingly clear that gut
microorganisms and the intestinal barrier function play an important role in
gut-brain communications, which are also associated with psychiatric disorders.
Gut-brain communication seems to be an important working mechanism for
probiotics. However, the effects of probiotics on neural and cognitive
functioning in humans are still unclear.
Study objective
To investigate the impact of the multispecies probiotic product
Ecologic*Barrier on neurocognitive measures of emotion and executive
functioning.
Study design
We will use a double blind, randomized, placebo-controlled, between-subject
study design. Subjects will be tested twice using fMRI, once before and once
after four weeks of Ecologic*Barrier supplementation or placebo.
Intervention
For a 4-week period, subjects will receive either one daily dose of 2 grams of
the multispecies probiotic product Ecologic® Barrier (Bifidobacterium bifidum
W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37,Lactobacillus
brevis W63, Lactobacillus casei W56,Lactobacillus salivarius W24, Lactococcus
lactis W19,Lactococcus lactis W58, with a total cell count of 2.5 x 109 colony
forming units (cfu) per gram, blended on a carrier material consisting of maize
starch, maltodextrin, vegetable protein and a mineral mix) or 2 grams of the
placebo, containing only the carrier material.
Study burden and risks
MRI does not involve any risks when precaution is taken (e.g. no pacemaker, no
metal objects, etc.), which will be done by an extensive screening. The
probiotic EcologicBarrier is freely available to consumers and research has
shown that the risks of taking the probiotic and placebo are negligible (i.e.
excellent EFSA profile).
The burden of participation consists of 2 lab visits, with 4 weeks in between:
3 hours per visit, of which 1 hour fMRI (including 30 minutes tasks) that will
be followed by neuropsychological tests and questionnaires. We will also take
saliva samples (5 per visit) and fecal samples (2 in total). During the
intervention time period, subjects have to adhere to some simple restrictions
with respect to the consumption of Ecologic*Barrier.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL55406.091.15 |
| OMON | NL-OMON27864 |