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

The impact of EcologicBarrier on neurocognitive measures of emotion & executive functioning - Probiotics and Behavior

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43866
Enrollment
60
Registered
2016-02-18
Start date
2016-04-19
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fundamenteel onderzoek (gezonde volwassenen) not applicable

Interventions

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, Lactobac

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • Previous or current neurological, psychiatric, gastrointestinal or endocrine disorders, or other relevant medical history • Current or recent (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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)