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Cognitive and mood effects of a dietary supplement containing probiotics, vitamins and zinc: a randomized, double-blind, placebo-controlled crossover study in healthy humans.

Cognitive and mood effects of a dietary supplement containing probiotics, vitamins and zinc: a randomized, double-blind, placebo-controlled crossover study in healthy humans. - Psychobiotc study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51267
Enrollment
44
Registered
2021-07-05
Start date
2021-09-15
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

Mild/moderate stress level mood and cognitive functions Neurological disorders

Interventions

The participants are assigned randomly to 2 equal-size groups on the first testing day. During the intervention period, one-half of the total sample receive once daily the active product as a stick,

Sponsors

Wageningen Universiteit
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * 18-60 years old * BMI in healthy range (18.5-25 Kg/m2) * Score of mild/moderate stress level on DASS-42 (Depression, Anxiety and Stress Scale) * Available for study visits

Exclusion criteria

Exclusion criteria: - Type 1 diabetes (one of the main metabolites of Lactobacillus is acetic acid. In animal studies, acetic acid has been reported to increase liver lipid metabolism and fat digestion affects the pancreas, and this has also been used in studies on obesity) - Currently using any medication or dietary supplements that can interfere with the research, or the interpretation of the research results, such as: melatonin, vitamin E, multivitamins, vitamin B complex, ginkgo Bilbao, fish oil or other cognitive enhancing nutritional or herbal supplements. - Daily concentrated sources of probiotics than the research products provided (eg probiotic / prebiotic tablets, capsules, powders,). - Taking any medication at this time or in the 4 weeks prior to the first day of study that would interfere with the purpose of the study, such as psychoactive drugs (anxiolytics, sedatives, hypnotics, antipsychotics, antidepressants, anticonvulsants, centrally acting corticosteroids, opioid painkillers)) Excessive caffeine intake (> 500 mg per day, approximately the amount of caffeine in 5 cups of brewed coffee) - Excessive alcohol consumption (corresponding to the man drinking more than 21 units / week and for the woman more than 14 units / week) for 2 weeks prior to screening and during the intervention period - Recent (offer for screening in the last 4 weeks) of ongoing antibiotic therapy during the intervention period - History of self-reported dementia, stroke and other neurological conditions - Being an employee of Wageningen University, division Human Nutrition and Health and Food quality and design

Design outcomes

Primary

MeasureTime frame
To evaluate a probiotic formula, including selected probiotic strains, vitamin D, B6, and zinc on cognitive performance CogState Battery has been widely used in the context of measuring cognitive functioning. Cognitive tasks related to verbal learning and memory processing speed, visual attention, visual learning, working memory - The Cogstate International Shopping List Test (ISLT) is a word list learning test that has several advantages for sensitively measuring episodic memory in worldwide clinical trials, including standardization of administration, cultural appropriateness. This test has been specially developed to assess verbal list learning and memory in people of different language and cultural backgrounds - The Detection Task (DET): The DET is a measure of psychomotor function and information processing speed using a simple reaction time paradigm with playing card stimuli. - The identification test (IDN): The identification task is a measure of visual attention and uses a chosen reaction time paradigm with playing card stimuli. - The one card learning test (OCL): The one card learning task is a measure of visual learning and memory that uses a pattern-separation paradigm with playing card stimuli. - The one-back test (ONB): The one-back task is a measure of working memory and uses a well-validated n-back paradigm with playing card stimuli. - Social-Emotional Cognition Test: Measures Emotional Recognition

Secondary

MeasureTime frame
1.Measure the three related negative emotional states of depression, anxiety, and tension/stress using the 42-item self-report instrument DASS. 2. Test cognitive reactivity to sad mood, which is an index of cognitive vulnerability to depression, with LEIDS-r questionnaires, a self-report questionnaire. It consists of 34 items that describe different situations. 3. Gut Microbiome Analysis in Stool

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)