Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue
- Conditions
- Mental FatigueCognitive FunctionMoodMental Health - Studies of normal psychology, cognitive function and behaviour
- Registration Number
- ACTRN12618001457235
- Lead Sponsor
- Swinburne University of Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 128
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method