Examining the Effects of One-Month Probiotic Treatment on Mental Fatigue

NCT03611478 | Completed Phase 2

• 1 other identifier: NH-03884
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Fatigue; Cognitive Function; Mood

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (57)

• RVIP number correct

  28 days

• RVIP reaction time

  28 days

• RVIP false alarms

  28 days

• Serial threes subtraction total

  28 days

• Serial threes errors

  28 days

Study Arms (2)

Probiotic formulation

EXPERIMENTAL

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

Dietary Supplement: Probiotic formulation

Placebo

PLACEBO COMPARATOR

Matching placebo to be taken once daily by mouth for 28 days.

Dietary Supplement: Placebo

Interventions

Probiotic formulation DIETARY_SUPPLEMENT

Probiotic capsule

Probiotic formulation

Placebo DIETARY_SUPPLEMENT

Placebo capsule identical in taste and appearance to probiotic capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)).
• 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.

You may not qualify if:

• History of dementia, stroke and other neurological conditions.
• Traumatic loss of consciousness in the last 12 months.
• History of epilepsy or Parkinson's disease.
• 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).
• 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.

Sponsors & Collaborators

• Swinburne University of Technology: lead
• DuPont Nutrition and Health: collaborator

Study Sites (1)

Centre for Human Psychopharmacology, Swinburne University of Technology

Hawthorn, Victoria, 3122, Australia

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Andrew B Scholey, PhD

  Swinburne University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a triple-blind trial, with randomisation being conducted by a disinterested third party. Unblinding will not occur until data analysis is complete.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Half the participants will receive the probiotic formulation while the other half will receive placebo.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: August 30, 2018
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)