Clinical trial NCT03611478: Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
Official title: Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mental Fatigue
Cognitive Function
Mood
Lead sponsor: Swinburne University of Technology
Sponsor class: OTHER
Collaborators: name: DuPont Nutrition and Health
First posted: 2018-08-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half the participants will receive the probiotic formulation while the other half will receive placebo.
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Mental fatigue score (VAS-mental fatigue)
timeFrame: 28 days
Secondary outcomes:
measure: RVIP number correct
timeFrame: 28 days
measure: RVIP reaction time
timeFrame: 28 days
measure: RVIP false alarms
timeFrame: 28 days
measure: Serial threes subtraction total
timeFrame: 28 days
measure: Serial threes errors
timeFrame: 28 days
measure: Serial sevens total
timeFrame: 28 days
measure: Serial sevens errors
timeFrame: 28 days
measure: Immediate word recall - correct
timeFrame: 28 days
measure: Immediate word recall - errors
timeFrame: 28 days
measure: Immediate word recall - intrusions
timeFrame: 28 days
measure: Delayed word recall - Correct
timeFrame: 28 days
measure: Delayed word recall - errors
timeFrame: 28 days
measure: Delayed word recall - intrusions
timeFrame: 28 days
measure: Delayed word recognition - reaction time
timeFrame: 28 days
measure: Word recognition - original words accuracy
timeFrame: 28 days
measure: Word recognition - distractor words accuracy
timeFrame: 28 days
measure: Self-reported alertness score
timeFrame: 28 days
measure: Self-reported contentment score
timeFrame: 28 days
measure: Self-reported calmness score
timeFrame: 28 days
measure: Difference in self-reported stress score (VAS-stress) before and after a cognitive load
timeFrame: 28 days
measure: Self-reported stress score (VAS-stress) - pre-CDB only
timeFrame: 28 days
measure: Difference in self-reported physical fatigue score (VAS-fatigue) before and after a cognitive load
timeFrame: 28 days
measure: Self-reported physical fatigue score (VAS-fatigue) - pre-CDB only
timeFrame: 28 days
measure: Self-reported state anxiety (STAI) before and after a cognitive load
timeFrame: 28 days
measure: Mental fatigue score on the Chalder Fatigue Scale
timeFrame: 28 days
measure: Physical fatigue score on the Chalder Fatigue Scale
timeFrame: 28 days
measure: Total fatigue score on the Chalder Fatigue Scale
timeFrame: 28 days
measure: Self-reported sleep quality - total score
timeFrame: 28 days
measure: Self-reported duration of sleep score
timeFrame: 28 days
measure: Self-reported sleep disturbance score
timeFrame: 28 days
measure: Self-reported sleep latency score
timeFrame: 28 days
measure: Self-reported daytime dysfunction score
timeFrame: 28 days
measure: Self-reported habitual sleep efficiency score
timeFrame: 28 days
measure: Subjective sleep quality score
timeFrame: 28 days
measure: Self-reported use of sleep medications score
timeFrame: 28 days
measure: Self-reported vitality score (SF-36)
timeFrame: 28 days
measure: Self-reported physical functioning score (SF-36)
timeFrame: 28 days
measure: Self-reported bodily pain score (SF-36)
timeFrame: 28 days
measure: Self-reported general health perceptions score (SF-36)
timeFrame: 28 days
measure: Self-reported physical role functioning score (SF-36)
timeFrame: 28 days
measure: Self-reported emotional role functioning score (SF-36)
timeFrame: 28 days
measure: Self-reported social role functioning score (SF-36)
timeFrame: 28 days
measure: Self-reported mental health score (SF-36)
timeFrame: 28 days
measure: Self-reported depression score (DASS-21)
timeFrame: 28 days
measure: Self-reported anxiety score (DASS-21)
timeFrame: 28 days
measure: Self-reported stress score (DASS-21)
timeFrame: 28 days
measure: Self-reported confrontive coping score (WAYS)
timeFrame: 28 days
measure: Self-reported distancing score (WAYS)
timeFrame: 28 days
measure: Self-reported self-controlling score (WAYS)
timeFrame: 28 days
measure: Self-reported seeking social support score (WAYS)
timeFrame: 28 days
measure: Self-reported accepting responsibility score (WAYS)
timeFrame: 28 days
measure: Self-reported escape-avoidance score (WAYS)
timeFrame: 28 days
measure: Self-reported planful problem-solving score (WAYS)
timeFrame: 28 days
measure: Self-reported positive re-appraisal score (WAYS)
timeFrame: 28 days
measure: Positive effects of on-trial experiences
timeFrame: 28 days
measure: Negative effects of on-trial experiences
timeFrame: 28 days
measure: Unusual effects of on-trial experiences
timeFrame: 28 days
Other outcomes:
Locations:
city: Hawthorn
country: Australia
facility: Centre for Human Psychopharmacology, Swinburne University of Technology
state: Victoria
Study officials:
affiliation: Swinburne University of Technology
name: Andrew B Scholey, PhD
role: PRINCIPAL_INVESTIGATOR
References: