Trials / Completed
CompletedNCT03611478
Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Swinburne University of Technology · Academic / Other
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to demonstrate the effects of 28-days supplementation with a novel probiotic formulation on mental fatigue following a cognitive load in healthy adults. Half of the participants will receive the probiotic formulation while the other half will receive placebo.
Detailed description
A total of 128 participants will be recruited to take part in this trial. The supplement contains selected strains of lactobacilli and bifidobacteria which have been well studied in human clinical trials. Previous clinical trials have demonstrated improvements in cognitive function and mood after supplementation with various combinations of lactobacilli and bifidobacteria. The specific strains present in the current investigation have been studied in a number of clinical trials in which no adverse events were linked to the strains. The benefits of probiotic supplements on health is well established, and has led to an increase in use, as well as the addition of probiotic strains in dietary supplements. Despite this, only a small number of controlled trials have directly investigated the cognitive benefits associated with probiotic supplementation. The current study therefore aims to investigate the anti-fatigue effects of a probiotic supplement after a period of cognitive demand. We will be measuring the effects of the probiotic supplement compared to a placebo using assessments of mental fatigue, cognition, memory and mood.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Probiotic formulation | Probiotic capsule |
| DIETARY_SUPPLEMENT | Placebo | Placebo capsule identical in taste and appearance to probiotic capsule |
Timeline
- Start date
- 2018-08-30
- Primary completion
- 2019-06-25
- Completion
- 2019-06-25
- First posted
- 2018-08-02
- Last updated
- 2019-09-27
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT03611478. Inclusion in this directory is not an endorsement.