Mental FatiguePhase 2NCT03611478
Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
A Phase 2 study testing Probiotic formulation in people with Mental Fatigue and Cognitive Function, run by Swinburne University of Technology at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Fatigue, Cognitive Function, Mood
- What is being tested?
- Probiotic formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Aug 2018to 25 Jun 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, aged 18-50 years, inclusive.
- Willing and able to provide written informed consent.
- Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- Agreement to comply with the protocol and study restrictions.
- Available for all study visits.
- Females of child-bearing potential required to provide a negative urine pregnancy test and be using effective contraception (e.g. surgically sterilized (tubal ligation or hysterectomy or partner is post-vasectomy, with sterility confirmed) or use an IUD (intrauterine device), a diaphragm or condom combined with contraceptive sponge, foam or jelly, or be using an oral contraceptive (the pill) for at least 2 cycles before the Screening-visit (Visit 0)).
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- Fluent in written and spoken English.
- In good general health as judged by the Investigator/Clinical advisor based on medical history.
- Must have normal, or corrected to normal vision.
- Body mass index between 18.5 and 29.9kg/m2 (inclusive).
- Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
- Participant is willing and able to comfortably abstain from caffeine for 10 hours prior to and throughout the test visits, (2-3 hours).
- Participant is willing to abstain from alcohol for 12 hours and vigorous physical activity for 12 hours prior to all study visits.
Who cannot join
- History of dementia, stroke and other neurological conditions.
- Traumatic loss of consciousness in the last 12 months.
- History of epilepsy or Parkinson's disease.
- Formal diagnosis of anxiety, depression or any psychiatric disorder that the Principal Investigator believes would interfere with the objectives of the study and requiring treatment (prescription of antidepressant, antipsychotic or other long term medication and/or referral for long term psychotherapy) in the last 2 years. Brief interventions for normal life events such as exam anxiety or bereavement are not an exclusion.
- Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic (including diabetes or cardiovascular disease), endocrine or bleeding disorders, neurodevelopmental or any condition which contraindicates, in the Principal Investigator's judgement, entry to the study.
- Uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood pressure >100 mm Hg).
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- Currently taking (from day of screening onwards) or have previously taken (last 4 weeks prior to screening) psychoactive medication (anxiolytics, sedatives, hypnotics, anti-psychotics, anti-depressants, anti-convulsants, centrally acting corticosteroids, opioid pain relievers).
- Currently taking (from day of screening onwards) medication that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results such as:
- high dose anticoagulant medication such as warfarin, heparin, clopidogrel, dabigatran, ticagrelor
- non-steroidal anti-inflammatory drugs (NSAIDS; excluded only for daily use)
- over-the-counter sleep medication (not categorized as sedatives, hypnotics or anti-depressants)
- anti-cholinergic drugs or acetylcholinesterase inhibitors: bethanechol (Urecholine), donepezil (Aricept), rivastigmine (Exelon), galantamine (Reminyl), neostigmine (Prostigmin)
- anti-histamines that cause drowsiness (eg. Ranitidine)
- pseudoephedrine and phenylephrine
- Currently taking (from day of screening onwards) dietary supplements that the Principal Investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results such as: melatonin, vitamin E, multivitamins, B vitamin complex, ginkgo biloba, fish oil, St. John's Wort or other cognitive enhancing dietary or herbal supplements over the study period.
- Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period.
- Daily consumption of concentrated sources of probiotics and/or prebiotics within 2 weeks of screening and throughout the intervention period other than the provided study products (e.g., probiotic/prebiotic tablets, capsules, drops or powders or yoghurts/yoghurt drinks containing probiotics).
- Pregnant or lactating female, or pregnancy planned during intervention period.
- Have self-reported dyslexia.
- Current misuse of alcohol, drugs, or prescription medication.
- Current smoker.
- Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to screening and during the intervention period.
- Excessive alcohol consumption (drinking on 5 or more days a week) for 3 weeks prior to screening and during the intervention period.
- Contraindication to any substance in the investigational product.
- Participation in another study with any investigational product within 30 days of screening and during the intervention period.
- Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
- Participant under administrative or legal supervision.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Centre for Human Psychopharmacology, Swinburne University of Technology
Hawthorn, Victoria, 3122
About this study
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.
Read the 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
- Mental Fatigue, Cognitive Function, Mood
- Being tested
- Probiotic formulation, Placebo
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic formulationDietary supplement
Probiotic capsule
PlaceboDietary supplement
Placebo capsule identical in taste and appearance to probiotic capsule
| Study group | Role | What they receive |
|---|---|---|
| Probiotic formulation | Experimental | Contains a probiotic formulation. One capsule to be taken by mouth once daily for 28 days. Receives: Dietary Supplement: Probiotic formulation |
| Placebo | Placebo comparator | Matching placebo to be taken once daily by mouth for 28 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental fatigue score (VAS-mental fatigue)
Difference in mental fatigue score as the participant moves through six cycles of a cognitive demand battery (CDB). The cognitive demand battery consists of three tasks (RVIP, serial threes and serial sevens, described below), and is designed to increase cognitive load. Six cycles of the battery are completed in succession at each testing visit. The mental fatigue scale (VAS-mental fatigue) is completed after each cycle of the CDB (6 times over the course of one hour, per visit). Participants rate their level of mental fatigue on a 100-mm scale from "not at all" to "extremely". The primary outcome is difference in mental fatigue score (VAS-mental fatigue) as the participant moves through the six cycles of the CDB, (after cognitive load) absolute change from baseline (Visit 2) to 28 days (Visit 3) between the active vs placebo group.
Measured: 28 days
Secondary outcomes (57)
RVIP number correct
Percentage of target strings correctly detected on the rapid visual information processing (RVIP) task throughout each of the six cycles of the CDB. In this task, which lasts for 5 minutes, a series of numbers rapidly appear on the screen one at a time. Participants are instructed to press the space bar whenever they detect a sequence of either 3 consecutive odd or 3 consecutive even numbers.
Measured: 28 days
RVIP reaction time
Average reaction time for correct detections (RVIP) throughout each of the six cycles of the CDB.
Measured: 28 days
RVIP false alarms
The number of false alarms (RVIP) throughout each of the six cycles of the CDB
Measured: 28 days
Serial threes subtraction total
Total number of subtractions on the serial threes subtraction task, regardless of whether correct or incorrect, throughout each of the six cycles of the CDB. In this two minute task, participants are given a starting number and instructed to subtract three from this number. They must then type in the number they are left with and press enter. After this no numbers are visible but the participant must continue to subtract three and enter their responses.
Measured: 28 days
Serial threes errors
Total number of incorrect subtractions (serial threes subtraction task) throughout each of the six cycles of the CDB
Measured: 28 days
Serial sevens total
Total number of subtractions (serial sevens subtraction task) throughout each of the six cycles of the CDB. This task is the same as the serial threes task, except that participants must subtract seven instead of three.
Measured: 28 days
Serial sevens errors
Total number of errors (serial sevens subtraction task) throughout each of the six cycles of the CDB
Measured: 28 days
Immediate word recall - correct
The number of correctly identified words in the immediate word recall task. Participants see a list of 15 words that they are instructed to remember. After seeing the last word, the participant has 60 seconds to write down as many of the words as they can remember.
Measured: 28 days
Immediate word recall - errors
The number of errors in the immediate word recall task (words not included in the original list)
Measured: 28 days
Immediate word recall - intrusions
The number of intrusions in the immediate word recall task (words similar to those included in the original list but not identical).
Measured: 28 days
Delayed word recall - Correct
The number of correctly identified words in the delayed word recall task. After completing the CDB (approximately one hour after presentation of the 15 words), the participant has 60 seconds to write down as many of the words as they can remember from the original list.
Measured: 28 days
Delayed word recall - errors
The number of errors in the delayed word recall task (words not included in the original list)
Measured: 28 days
Delayed word recall - intrusions
The number of intrusions in the delayed word recall task (words similar to those included in the original list but not identical).
Measured: 28 days
Delayed word recognition - reaction time
Mean reaction time to word recognition in delayed word recognition task following cognitive load. After participants have viewed the word list and completed the immediate word recall task, they complete the CDB which lasts for one hour. On completion of the CDB, participants complete a word recognition task. In this task, the original 15 target words plus an additional 15 distractor words are presented one at a time, in a randomized order. Participants are instructed to indicate whether or not they recognize the word from the original list by pressing the 'Yes' or 'No' button as appropriate as quickly as possible, mean reaction times are measured in msec.
Measured: 28 days
Word recognition - original words accuracy
Accuracy of responses (%) to original target words in delayed word recognition task following cognitive load (CDB).
Measured: 28 days
Word recognition - distractor words accuracy
Accuracy of responses (%) to novel distractor words in delayed word recognition following cognitive load (CDB).
Measured: 28 days
Self-reported alertness score
Participants are presented with a number of 100-mm visual analogue scales (Bond-Lader mood scales) where they indicate their current feelings. The alertness score is calculated by averaging scores on lines anchored by alert-drowsy, attentive-dreamy, lethargic-energetic, muzzy-clearheaded, well-coordinated-clumsy, mentally slow-quick witted, strong-feeble, interested-bored, incompetent-proficient. This is completed before and after the CDB.
Measured: 28 days
Self-reported contentment score
Participants are presented with a number of 100-mm visual analogue scales (Bond-Lader mood scales) where they indicate their current feelings. The contentment score is calculated by averaging scores on lines anchored by contented-discontented, troubled-tranquil, happy-sad, antagonistic-friendly, withdrawn-sociable. This is completed before and after the CDB.
Measured: 28 days
Self-reported calmness score
Participants are presented with a number of 100-mm visual analogue scales (Bond-Lader mood scales) where they indicate their current feelings. The calmness score is calculated by averaging scores on lines anchored by calm-excited, tense-relaxed. This is completed before and after the CDB.
Measured: 28 days
Difference in self-reported stress score (VAS-stress) before and after a cognitive load
The Stress Visual Analogue Scale (VAS-Stress) consists of a single 100 mm line with end-points labelled 'Not at all' and 'Very much so'. Participants are instructed to mark the line, depending on how "stressed" they feel at that point in time. This is completed twice in each session, once prior to the CDB, and once after the battery is complete. The difference between pre- and post-CDB score is calculated, and the difference is compared between baseline and 28 days.
Measured: 28 days
Self-reported stress score (VAS-stress) - pre-CDB only
The Stress Visual Analogue Scale (VAS-Stress) consists of a single 100 mm line with end-points labelled 'Not at all' and 'Very much so'. Participants are instructed to mark the line, depending on how "stressed" they feel at that point in time. The pre-CDB score is compared between baseline and 28 days to provide an assessment of stress without cognitive load.
Measured: 28 days
Difference in self-reported physical fatigue score (VAS-fatigue) before and after a cognitive load
The Physical Fatigue Visual Analogue Scale (VAS-fatigue) consists of a single 100 mm line with end-points labelled 'Not at all' and 'Very much so'. Participants are instructed to mark the line, depending on how "physically fatigued" they feel at that point in time. This is completed twice in each session, once prior to the CDB, and once after the battery is complete. The difference between pre- and post-CDB score is calculated, and the difference is compared between baseline and 28 days.
Measured: 28 days
Self-reported physical fatigue score (VAS-fatigue) - pre-CDB only
The Physical Fatigue Visual Analogue Scale (VAS-Fatigue) consists of a 100 mm line with end-points labelled 'Not at all' and 'Very much so'. Participants are instructed to mark the line, depending on how "physically fatigued" they feel at that point in time. The pre-CDB score is compared between baseline and 28 days to provide an assessment of physical fatigue without cognitive load.
Measured: 28 days
Self-reported state anxiety (STAI) before and after a cognitive load
The 'State' subscale of the STAI contains 20 items, and requires participants to rate how much they feel like each item at the time of response. The scale is scored on a 4-point scale ranging from 'not at all' to 'very much so'. Scores range from 20 to 80, with higher scores indicating higher levels of anxiety. Participants will be required to complete the state version of the STAI twice per session, once before the commencement of the CDB, and once at completion.
Measured: 28 days
Mental fatigue score on the Chalder Fatigue Scale
The 14-item Chalder Fatigue Scale (CFS) measures both physical and mental fatigue, as well as a total fatigue rating, on a 4-point scale ranging from 'better than usual' to 'much worse than usual'.
Measured: 28 days
Physical fatigue score on the Chalder Fatigue Scale
The 14-item CFS measures both physical and mental fatigue, as well as a total fatigue rating, on a 4-point scale ranging from 'better than usual' to 'much worse than usual'.
Measured: 28 days
Total fatigue score on the Chalder Fatigue Scale
The 14-item CFS measures both physical and mental fatigue, as well as a total fatigue rating, on a 4-point scale ranging from 'better than usual' to 'much worse than usual'.
Measured: 28 days
Self-reported sleep quality - total score
The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Measured: 28 days
Self-reported duration of sleep score
The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Measured: 28 days
Self-reported sleep disturbance score
The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Measured: 28 days
Self-reported sleep latency score
The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Measured: 28 days
Self-reported daytime dysfunction score
The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Measured: 28 days
Self-reported habitual sleep efficiency score
The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Measured: 28 days
Subjective sleep quality score
The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Measured: 28 days
Self-reported use of sleep medications score
The Pittsburgh Sleep Quality Index (PSQI) was originally designed to measure sleep quality and disturbance in clinical populations, and has been subsequently utilized in a number of research settings. The PSQI is a self-rated scale measured over a one-month interval. The scale is comprised of 19 individual items that generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleep medications, and daytime dysfunction. The scale also has five items to be answered by a bed partner, if applicable, but these answers are not included in the scoring of the scale. For the current study, these five questions will be removed from the scale.
Measured: 28 days
Self-reported vitality score (SF-36)
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Measured: 28 days
Self-reported physical functioning score (SF-36)
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Measured: 28 days
Self-reported bodily pain score (SF-36)
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Measured: 28 days
Self-reported general health perceptions score (SF-36)
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Measured: 28 days
Self-reported physical role functioning score (SF-36)
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Measured: 28 days
Self-reported emotional role functioning score (SF-36)
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Measured: 28 days
Self-reported social role functioning score (SF-36)
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Measured: 28 days
Self-reported mental health score (SF-36)
The SF-36 is a 36-item survey of health and well-being. The scale consists of eight domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. The SF-36 will be completed once per session.
Measured: 28 days
Self-reported depression score (DASS-21)
The Depression, Anxiety and Stress scale (DASS-21) is a 21-item questionnaire that is split into three factors: depression, anxiety and stress. The DASS-21 is made up of affect-related questions pertaining to both physical (e.g. 'dry mouth') and mood symptoms (e.g. 'down-hearted'). Each item is scored on a 4-point scale from 0 to 3, with higher scores indicating a higher degree of dysfunction. It is important to note that lower scores reflect a lack of symptoms and not a more positive mood. Furthermore, as the experience of such symptoms is common in every-day life, the DASS-21 is considered suitable for use in non-clinical settings.
Measured: 28 days
Self-reported anxiety score (DASS-21)
The Depression, Anxiety and Stress scale (DASS-21) is a 21-item questionnaire that is split into three factors: depression, anxiety and stress. The DASS-21 is made up of affect-related questions pertaining to both physical (e.g. 'dry mouth') and mood symptoms (e.g. 'down-hearted'). Each item is scored on a 4-point scale from 0 to 3, with higher scores indicating a higher degree of dysfunction. It is important to note that lower scores reflect a lack of symptoms and not a more positive mood. Furthermore, as the experience of such symptoms is common in every-day life, the DASS-21 is considered suitable for use in non-clinical settings.
Measured: 28 days
Self-reported stress score (DASS-21)
The Depression, Anxiety and Stress scale (DASS-21) is a 21-item questionnaire that is split into three factors: depression, anxiety and stress. The DASS-21 is made up of affect-related questions pertaining to both physical (e.g. 'dry mouth') and mood symptoms (e.g. 'down-hearted'). Each item is scored on a 4-point scale from 0 to 3, with higher scores indicating a higher degree of dysfunction. It is important to note that lower scores reflect a lack of symptoms and not a more positive mood. Furthermore, as the experience of such symptoms is common in every-day life, the DASS-21 is considered suitable for use in non-clinical settings.
Measured: 28 days
Self-reported confrontive coping score (WAYS)
The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Measured: 28 days
Self-reported distancing score (WAYS)
The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Measured: 28 days
Self-reported self-controlling score (WAYS)
The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Measured: 28 days
Self-reported seeking social support score (WAYS)
The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Measured: 28 days
Self-reported accepting responsibility score (WAYS)
The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Measured: 28 days
Self-reported escape-avoidance score (WAYS)
The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Measured: 28 days
Self-reported planful problem-solving score (WAYS)
The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Measured: 28 days
Self-reported positive re-appraisal score (WAYS)
The Ways of Coping Questionnaire (WAYS) is a 66-item scale designed to measure an individual's ability to cope with stress over the past week. The scale measures coping processes, not coping styles. The scale is divided into 8 subscales; confrontive coping, distancing, self-controlling, seeking social support, accepting responsibility, escape-avoidance, planful problem solving, positive re-appraisal. The scale is completed once per session.
Measured: 28 days
Positive effects of on-trial experiences
At the completion of the trial, participants will be asked an open-ended question about any positive effects they may have experienced on their physical or mental health during the study, to allow qualitative analysis of on-trial experiences.
Measured: 28 days
Negative effects of on-trial experiences
At the completion of the trial, participants will be asked an open-ended question about any negative effects they may have experienced on their physical or mental health during the study, to allow qualitative analysis of on-trial experiences.
Measured: 28 days
Unusual effects of on-trial experiences
At the completion of the trial, participants will be asked an open-ended question about any unusual effects they may have experienced on their physical or mental health during the study, to allow qualitative analysis of on-trial experiences.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start30 Aug 2018
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half the participants will receive the probiotic formulation while the other half will receive placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swinburne University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- DuPont Nutrition and Health
- Responsible party
- Principal investigator, Andrew Scholey, Swinburne University of Technology
- Investigators
- Andrew B Scholey, PhD, Principal investigator, Swinburne University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611478
- Sponsor's protocol ID
- NH-03884
- Status last verified
- Sep 2019
- First submitted
- 26 Jul 2018
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
- ClinicalTrials.gov ID
- NCT03611478
- Acronym / sponsor ID
- NH-03884
- Conditions
- Mental Fatigue, Cognitive Function, Mood
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Swinburne University of TechnologyUniversity, hospital or other
- Collaborators
- DuPont Nutrition and Health
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Half the participants will receive the probiotic formulation while the other half will receive placebo.
| Arm | Type | Receives |
|---|---|---|
| Probiotic formulation | Experimental | Dietary Supplement: Probiotic formulationContains a probiotic formulation. One capsule to be taken by mouth once daily for 28 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatching placebo to be taken once daily by mouth for 28 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male or female, aged 18-50 years, inclusive.
- Willing and able to provide written informed consent.
- Ability of the participant (in the Principal Investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects.
- Agreement to comply with the protocol and study restrictions.
- Available for all study visits.
Key exclusion criteria (27 listed)
- History of dementia, stroke and other neurological conditions.
- Traumatic loss of consciousness in the last 12 months.
- History of epilepsy or Parkinson's disease.
- Formal diagnosis of anxiety, depression or any psychiatric disorder that the Principal Investigator believes would interfere with the objectives of the study and requiring treatment (prescription of antidepressant, antipsychotic or other long term medication and/or referral for long term psychotherapy) in the last 2 years. Brief interventions for normal life events such as exam anxiety or bereavement are not an exclusion.
- Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal (irritable bowel syndrome (IBS), inflammatory bowel disease (IBD)), immunological, metabolic (including diabetes or cardiovascular disease), endocrine or bleeding disorders, neurodevelopmental or any condition which contraindicates, in the Principal Investigator's judgement, entry to the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic formulationProbiotic capsule | Dietary supplement | Probiotic formulation |
| PlaceboPlacebo capsule identical in taste and appearance to probiotic capsule | Dietary supplement | Placebo |
Primary outcome
Mental fatigue score (VAS-mental fatigue)
Time frame: 28 days
Difference in mental fatigue score as the participant moves through six cycles of a cognitive demand battery (CDB). The cognitive demand battery consists of three tasks (RVIP, serial threes and serial sevens, described below), and is designed to increase cognitive load. Six cycles of the battery are completed in succession at each testing visit. The mental fatigue scale (VAS-mental fatigue) is completed after each cycle of the CDB (6 times over the course of one hour, per visit). Participants rate their level of mental fatigue on a 100-mm scale from "not at all" to "extremely". The primary outcome is difference in mental fatigue score (VAS-mental fatigue) as the participant moves through the six cycles of the CDB, (after cognitive load) absolute change from baseline (Visit 2) to 28 days (Visit 3) between the active vs placebo group.
57 secondary outcomes
RVIP number correct
Time frame: 28 days
RVIP reaction time
Time frame: 28 days
RVIP false alarms
Time frame: 28 days
Serial threes subtraction total
Time frame: 28 days
Serial threes errors
Time frame: 28 days
Serial sevens total
Time frame: 28 days
Serial sevens errors
Time frame: 28 days
Immediate word recall - correct
Time frame: 28 days
Immediate word recall - errors
Time frame: 28 days
Immediate word recall - intrusions
Time frame: 28 days
Delayed word recall - Correct
Time frame: 28 days
Delayed word recall - errors
Time frame: 28 days
Delayed word recall - intrusions
Time frame: 28 days
Delayed word recognition - reaction time
Time frame: 28 days
Word recognition - original words accuracy
Time frame: 28 days
Word recognition - distractor words accuracy
Time frame: 28 days
Self-reported alertness score
Time frame: 28 days
Self-reported contentment score
Time frame: 28 days
Self-reported calmness score
Time frame: 28 days
Difference in self-reported stress score (VAS-stress) before and after a cognitive load
Time frame: 28 days
Self-reported stress score (VAS-stress) - pre-CDB only
Time frame: 28 days
Difference in self-reported physical fatigue score (VAS-fatigue) before and after a cognitive load
Time frame: 28 days
Self-reported physical fatigue score (VAS-fatigue) - pre-CDB only
Time frame: 28 days
Self-reported state anxiety (STAI) before and after a cognitive load
Time frame: 28 days
Mental fatigue score on the Chalder Fatigue Scale
Time frame: 28 days
Physical fatigue score on the Chalder Fatigue Scale
Time frame: 28 days
Total fatigue score on the Chalder Fatigue Scale
Time frame: 28 days
Self-reported sleep quality - total score
Time frame: 28 days
Self-reported duration of sleep score
Time frame: 28 days
Self-reported sleep disturbance score
Time frame: 28 days
Self-reported sleep latency score
Time frame: 28 days
Self-reported daytime dysfunction score
Time frame: 28 days
Self-reported habitual sleep efficiency score
Time frame: 28 days
Subjective sleep quality score
Time frame: 28 days
Self-reported use of sleep medications score
Time frame: 28 days
Self-reported vitality score (SF-36)
Time frame: 28 days
Self-reported physical functioning score (SF-36)
Time frame: 28 days
Self-reported bodily pain score (SF-36)
Time frame: 28 days
Self-reported general health perceptions score (SF-36)
Time frame: 28 days
Self-reported physical role functioning score (SF-36)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew B Scholey, PhD principal investigator
Swinburne University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic formulation in people with Mental Fatigue and Cognitive Function, run by Swinburne University of Technology at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental fatigue score (VAS-mental fatigue) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.