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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03611478




Registration number
NCT03611478
Ethics application status
Date submitted
26/07/2018
Date registered
2/08/2018
Date last updated
27/09/2019

Titles & IDs
Public title
Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
Scientific title
Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
Secondary ID [1] 0 0
NH-03884
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Fatigue 0 0
Cognitive Function 0 0
Mood 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Probiotic formulation
Treatment: Other - Placebo

Experimental: Probiotic formulation - Contains a probiotic formulation. One capsule to be taken by mouth once daily for 28 days.

Placebo comparator: Placebo - Matching placebo to be taken once daily by mouth for 28 days.


Treatment: Other: Probiotic formulation
Probiotic capsule

Treatment: Other: Placebo
Placebo capsule identical in taste and appearance to probiotic capsule
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mental fatigue score (VAS-mental fatigue)
Timepoint [1] 0 0
28 days
Secondary outcome [1] 0 0
RVIP number correct
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
RVIP reaction time
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
RVIP false alarms
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Serial threes subtraction total
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Serial threes errors
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
Serial sevens total
Timepoint [6] 0 0
28 days
Secondary outcome [7] 0 0
Serial sevens errors
Timepoint [7] 0 0
28 days
Secondary outcome [8] 0 0
Immediate word recall - correct
Timepoint [8] 0 0
28 days
Secondary outcome [9] 0 0
Immediate word recall - errors
Timepoint [9] 0 0
28 days
Secondary outcome [10] 0 0
Immediate word recall - intrusions
Timepoint [10] 0 0
28 days
Secondary outcome [11] 0 0
Delayed word recall - Correct
Timepoint [11] 0 0
28 days
Secondary outcome [12] 0 0
Delayed word recall - errors
Timepoint [12] 0 0
28 days
Secondary outcome [13] 0 0
Delayed word recall - intrusions
Timepoint [13] 0 0
28 days
Secondary outcome [14] 0 0
Delayed word recognition - reaction time
Timepoint [14] 0 0
28 days
Secondary outcome [15] 0 0
Word recognition - original words accuracy
Timepoint [15] 0 0
28 days
Secondary outcome [16] 0 0
Word recognition - distractor words accuracy
Timepoint [16] 0 0
28 days
Secondary outcome [17] 0 0
Self-reported alertness score
Timepoint [17] 0 0
28 days
Secondary outcome [18] 0 0
Self-reported contentment score
Timepoint [18] 0 0
28 days
Secondary outcome [19] 0 0
Self-reported calmness score
Timepoint [19] 0 0
28 days
Secondary outcome [20] 0 0
Difference in self-reported stress score (VAS-stress) before and after a cognitive load
Timepoint [20] 0 0
28 days
Secondary outcome [21] 0 0
Self-reported stress score (VAS-stress) - pre-CDB only
Timepoint [21] 0 0
28 days
Secondary outcome [22] 0 0
Difference in self-reported physical fatigue score (VAS-fatigue) before and after a cognitive load
Timepoint [22] 0 0
28 days
Secondary outcome [23] 0 0
Self-reported physical fatigue score (VAS-fatigue) - pre-CDB only
Timepoint [23] 0 0
28 days
Secondary outcome [24] 0 0
Self-reported state anxiety (STAI) before and after a cognitive load
Timepoint [24] 0 0
28 days
Secondary outcome [25] 0 0
Mental fatigue score on the Chalder Fatigue Scale
Timepoint [25] 0 0
28 days
Secondary outcome [26] 0 0
Physical fatigue score on the Chalder Fatigue Scale
Timepoint [26] 0 0
28 days
Secondary outcome [27] 0 0
Total fatigue score on the Chalder Fatigue Scale
Timepoint [27] 0 0
28 days
Secondary outcome [28] 0 0
Self-reported sleep quality - total score
Timepoint [28] 0 0
28 days
Secondary outcome [29] 0 0
Self-reported duration of sleep score
Timepoint [29] 0 0
28 days
Secondary outcome [30] 0 0
Self-reported sleep disturbance score
Timepoint [30] 0 0
28 days
Secondary outcome [31] 0 0
Self-reported sleep latency score
Timepoint [31] 0 0
28 days
Secondary outcome [32] 0 0
Self-reported daytime dysfunction score
Timepoint [32] 0 0
28 days
Secondary outcome [33] 0 0
Self-reported habitual sleep efficiency score
Timepoint [33] 0 0
28 days
Secondary outcome [34] 0 0
Subjective sleep quality score
Timepoint [34] 0 0
28 days
Secondary outcome [35] 0 0
Self-reported use of sleep medications score
Timepoint [35] 0 0
28 days
Secondary outcome [36] 0 0
Self-reported vitality score (SF-36)
Timepoint [36] 0 0
28 days
Secondary outcome [37] 0 0
Self-reported physical functioning score (SF-36)
Timepoint [37] 0 0
28 days
Secondary outcome [38] 0 0
Self-reported bodily pain score (SF-36)
Timepoint [38] 0 0
28 days
Secondary outcome [39] 0 0
Self-reported general health perceptions score (SF-36)
Timepoint [39] 0 0
28 days
Secondary outcome [40] 0 0
Self-reported physical role functioning score (SF-36)
Timepoint [40] 0 0
28 days
Secondary outcome [41] 0 0
Self-reported emotional role functioning score (SF-36)
Timepoint [41] 0 0
28 days
Secondary outcome [42] 0 0
Self-reported social role functioning score (SF-36)
Timepoint [42] 0 0
28 days
Secondary outcome [43] 0 0
Self-reported mental health score (SF-36)
Timepoint [43] 0 0
28 days
Secondary outcome [44] 0 0
Self-reported depression score (DASS-21)
Timepoint [44] 0 0
28 days
Secondary outcome [45] 0 0
Self-reported anxiety score (DASS-21)
Timepoint [45] 0 0
28 days
Secondary outcome [46] 0 0
Self-reported stress score (DASS-21)
Timepoint [46] 0 0
28 days
Secondary outcome [47] 0 0
Self-reported confrontive coping score (WAYS)
Timepoint [47] 0 0
28 days
Secondary outcome [48] 0 0
Self-reported distancing score (WAYS)
Timepoint [48] 0 0
28 days
Secondary outcome [49] 0 0
Self-reported self-controlling score (WAYS)
Timepoint [49] 0 0
28 days
Secondary outcome [50] 0 0
Self-reported seeking social support score (WAYS)
Timepoint [50] 0 0
28 days
Secondary outcome [51] 0 0
Self-reported accepting responsibility score (WAYS)
Timepoint [51] 0 0
28 days
Secondary outcome [52] 0 0
Self-reported escape-avoidance score (WAYS)
Timepoint [52] 0 0
28 days
Secondary outcome [53] 0 0
Self-reported planful problem-solving score (WAYS)
Timepoint [53] 0 0
28 days
Secondary outcome [54] 0 0
Self-reported positive re-appraisal score (WAYS)
Timepoint [54] 0 0
28 days
Secondary outcome [55] 0 0
Positive effects of on-trial experiences
Timepoint [55] 0 0
28 days
Secondary outcome [56] 0 0
Negative effects of on-trial experiences
Timepoint [56] 0 0
28 days
Secondary outcome [57] 0 0
Unusual effects of on-trial experiences
Timepoint [57] 0 0
28 days

Eligibility
Key inclusion criteria
1. Male or female, aged 18-50 years, inclusive.
2. Willing and able to provide written informed consent.
3. 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.
4. Agreement to comply with the protocol and study restrictions.
5. Available for all study visits.
6. 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)).
7. Fluent in written and spoken English.
8. In good general health as judged by the Investigator/Clinical advisor based on medical history.
9. Must have normal, or corrected to normal vision.
10. Body mass index between 18.5 and 29.9kg/m2 (inclusive).
11. Participant is willing to maintain habitual diet (including caffeine and alcohol) and physical activity patterns throughout the study period.
12. Participant is willing and able to comfortably abstain from caffeine for 10 hours prior to and throughout the test visits, (2-3 hours).
13. Participant is willing to abstain from alcohol for 12 hours and vigorous physical activity for 12 hours prior to all study visits.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of dementia, stroke and other neurological conditions.
2. Traumatic loss of consciousness in the last 12 months.
3. History of epilepsy or Parkinson's disease.
4. 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.
5. 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.
6. Uncontrolled hypertension (systolic blood pressure > 160mm Hg or diastolic blood pressure >100 mm Hg).
7. 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).
8. 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
9. 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.
10. Recent (within last 4 weeks prior to screening) or ongoing antibiotic therapy during the intervention period.
11. 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).
12. Pregnant or lactating female, or pregnancy planned during intervention period.
13. Have self-reported dyslexia.
14. Current misuse of alcohol, drugs, or prescription medication.
15. Current smoker.
16. Self-declared illicit drug users (including cannabis and cocaine) for 3 weeks prior to screening and during the intervention period.
17. Excessive alcohol consumption (drinking on 5 or more days a week) for 3 weeks prior to screening and during the intervention period.
18. Contraindication to any substance in the investigational product.
19. Participation in another study with any investigational product within 30 days of screening and during the intervention period.
20. Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study.
21. Participant under administrative or legal supervision.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/06/2019
Sample size
Target
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Centre for Human Psychopharmacology, Swinburne University of Technology - Hawthorn
Recruitment postcode(s) [1] 0 0
3122 - Hawthorn

Funding & Sponsors
Primary sponsor type
Other
Name
Swinburne University of Technology
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
DuPont Nutrition and Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03611478
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew B Scholey, PhD
Address 0 0
Swinburne University of Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03611478