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Understanding gut feelings: Probiotics and cognition

Understanding gut feelings: Probiotics and cognition - Probiotics and cognition

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46368
Enrollment
140
Registered
2017-09-29
Start date
2017-10-25
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

niet van toepassing op een aandoening not applicable

Interventions

Following Steenbergen and colleagues (2015) and de Noos and colleagues (2015), the probiotic group will receive 2 grams freeze-dried powder of the probiotic mixture Ecologic®Barrier daily for 35 day

Sponsors

Universiteit van Amsterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Healthy adult participants - aged 18-75 years - Females taking hormonal contraceptives; with the exception of females post-me nopause (In case of oral contraceptives, we will test participants in the weeks they commence the pill, i.e. at the end of the stop week. This way, we will ensure that hormone patterns are similar between the two test sessions. - Willingness to travel to the laboratory site, perform tasks and fill out questionnaires and adhere to the study intervention. - Fluency in Dutch language - written informed consent before inclusion

Exclusion criteria

Exclusion criteria: - Implementing or planning major changes in diet; e.g. attending a weight-loss program or changing to a vegetarian or vegan diet, or initiating new food supplements (including pro- or pre-biotics). - Current or past cardiac- (including high blood pressure), inflammatory- or auto-Immune-, gastrointestinal-, hepatic-, renal-, neurological- or psychiatric disorders or diseases, based on self-reported medical diagnosis and medication use. - excessive alcohol intake, defined as drinking more than 21 glasses of alcohol per week; - history of drug abuse or addiction; - Not using hormonal contraceptives (with the exception of post-menopause females) - Antibiotic use 3 months prior to the study - age below 18 or above 75.

Design outcomes

Primary

MeasureTime frame
Participants* mood is assessed through standardized questionnaires. Mood is measured through standardized self-report scales. We refer to the study protocol for a more detailed description of the primary parameters.

Secondary

MeasureTime frame
Cognitive and affective functioning will be measured through standardized cognitive computer tasks. Blood plasma is assessed for amino acid metabolism, markers of barrier functions and inflammation. HPA-functioning is assessed by repeated saliva samples. We emphasize that measurements will only be used to evaluate the effects of the intervention, but not for diagnostic purposes. Information about age, gender, and level of education will be collected in order to assess whether groups match on these background variables. Furthermore, non-verbal IQ, burnout complaints, alexithymia, interpersonal reactivity, autism spectrum symptoms, sleep quality, fatigue severity, state affect, anthropomorphic and physical measures (weight, BMI, fat%, musle%, heart rate, blood pressure) and bowel complaints will be assessed. These will mainly serve as covariates in the analyses of the primary parameters.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)