A randomised, double-blind, placebo-controlled, crossover trial investigating the effects of two nutraceutical combination formulas on mental fatigue, mood and neurocognitive performance in healthy adults.

Phase 3

Completed

• Conditions: Mental fatigue; Cognitive function; Self-rated mood; Cerebral blood flow and oxygen metabolism; Brain biochemistry; Diet and Nutrition - Other diet and nutrition disorders; Mental Health - Studies of normal psychology, cognitive function and behaviour; Neurological - Studies of the normal brain and nervous system

• Registration Number: ACTRN12615000062527
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Healthy adults aged 20 to 50 years

Exclusion Criteria

Participant experiences or evidence of delirium, confusion, or other disturbance of consciousness.
Participant has any diagnosed illness or disorder affecting cognitive function or mood such as depression, anxiety, stroke or dementia.
Individuals currently taking prescription medication other than a contraceptive pill.
Any significant concurrent illness including any bleeding disorders, coronary heart disease, diabetes, gastrointestinal disorder.
Any known or suspected food allergies (this would cover all ingredients in the investigational product).
Participant has a recent history of (within 12 months of V1) or strong potential for alcohol or substance abuse.
Participant is a female, who is pregnant, planning to be pregnant during the study period, or lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effects of supplementation on mental fatigue assessed by measuring changes in self-reported mental fatigue induced by the completion of the Cognitive Demand Battery (a cognitively taxing battery of tasks)[45-85 minutes post dose at each of the three visits where a treatment is given]

Secondary Outcome Measures

Name	Time	Method
Effects of supplementation on cognitive function assessed by measuring performance on both the Cognitive Demand Battery and the Swinburne University Computerized Cognitive Assessment Battery (SUCCAB)[45-85 minutes post dose at each of the three visits where a treatment is given];Effects of supplementation on self-reported mood assessed by the Bond and Lader Visual Analogue Scale[45-85 minutes post dose at each of the three visits where a treatment is given];Effects of supplementation on brain function (functional brain activity, cerebral blood flow oxygen metabolism and brain biochemistry) assessed by Functional Magnetic Resonance Imaging (fMRI) and Magnetic Resonance Spectroscopy (MRS)[90 minutes post dose at each of the three visits where a treatment is given]