Mood Clinical Trial
Official title:
The Effects of 12 Weeks Supplementation With a B-vitamin and Herbal Supplement on Neurocognitive Function and Mood: The Memory + Focus Clinical Trial (MAST - Memory and Attention Supplement Trial)
The aim of the present study is to evaluate chronic supplementation with Swisse Ultiboost Memory + Focus over a 12 week period on memory in individuals with optimal and sub-optimal nutrient profiles.
This study will have two co-primary outcomes; one each to measure memory and focus. Short
term memory will be measured by the spatial working memory task from the Swinburne University
Computerised Cognitive Assessment Battery. Focus will be measured by the incongruent version
of the stroop colour-word task from the Swinburne University Computerised Cognitive
Assessment Battery. Through investigations of blood vitamin markers, biomarkers of
inflammation and neuroimaging techniques, this study aims to provide insight to the
mechanisms through which the supplement is acting.
This study is a phase II clinical trial, which will follow a randomised, placebo-controlled,
double-blind, parallel groups design. One hundred and forty participants will complete a 12
week intervention, which will involve three testing visits to Swinburne University, as well
as in-home mood assessments. Of these, 60 participants will also complete an MRI component.
Participants will be randomly allocated to one of two groups; one receiving active
supplementation of Swisse Ultiboost Memory + Focus, and the other receiving a placebo
formulation.
Prior to participants being enrolled in the study a telephone screening interview will be
completed, to reduce the likelihood of ineligible participants attending study visits.
Eligible participants will complete three study visits; a Screening and Practice visit (V0),
Baseline Visit (V1), and the Final Visit (V2). The participant's baseline visit (V1) will be
scheduled within two weeks of their screening and practice visit (V0). The participant's
final visit (V2) will be scheduled 12 weeks (± 3 days) from the baseline visit (V1).
Therefore, it is anticipated that participation in the trial will last a maximum of 14 weeks.
For the 12 week supplementation period between their baseline (V1) and final (V2) visits,
participants will be instructed to consume one tablet, twice a day, of either Swisse
Ultiboost Memory + Focus or placebo, with a meal. Participants will be requested to abstain
from the treatment on the day of their final visit.
Participants will also be required to complete online mood assessments in their home, twice a
week for the duration of the 12 week supplementation period. Two laboratory assessment points
will be measured, at baseline (V1) and at the final visit (V2). Twenty four in-home
assessment points will be measured, twice a week during participation in the study.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05234476 -
Behavioral Activation Plus Savoring for University Students
|
N/A | |
Active, not recruiting |
NCT05516264 -
Behavioural and Physiological Responses to Dog Visits in Nursing Homes
|
N/A | |
Completed |
NCT05555186 -
The Effects of Bright Light Therapy on Adolescent's Sleep Quality and Well-being
|
N/A | |
Completed |
NCT04706806 -
Effect of Daily Vinegar Ingestion for Four Weeks on Mood State in Healthy College Students
|
N/A | |
Completed |
NCT04013451 -
The Kiss of Kindness Study II
|
N/A | |
Completed |
NCT03689348 -
Acute and Chronic Effects of Avena Sativa on Cognition and Stress
|
N/A | |
Completed |
NCT04440553 -
A Mobile App to Increase Physical Activity in Students
|
N/A | |
Completed |
NCT04505800 -
Tryptophan Supplementation to Improve Night Shift Workers' Health
|
N/A | |
Active, not recruiting |
NCT06082778 -
ZOE's Ferment Experiment
|
N/A | |
Completed |
NCT05100589 -
Effect of PeakATP on Mood, Reaction Time and Cognition
|
N/A | |
Completed |
NCT05559372 -
Energy Drink Effects on Performance, Mood, and Cardiovascular Outcomes
|
N/A | |
Active, not recruiting |
NCT04641689 -
Stand Up Kansas: An Intervention to Reduce Sedentary Behavior in the Home Work Environment
|
N/A | |
Active, not recruiting |
NCT01725425 -
The Effect of Portion Sizes on Mood
|
N/A | |
Completed |
NCT01794351 -
Cognitive Effects of 500mg Trans-resveratrol
|
N/A | |
Completed |
NCT05550610 -
Evaluation of Mindfulness and Yoga in Basic Combat Training
|
N/A | |
Recruiting |
NCT05939453 -
Impact of Bright Light Therapy on Prader-Willi Syndrome
|
N/A | |
Recruiting |
NCT05058872 -
Contraceptive Hormone and Reward Measurement (CHARM Study)
|
Phase 4 | |
Not yet recruiting |
NCT04551274 -
Music Therapy in Frontline Healthcare Workers
|
N/A | |
Completed |
NCT03105973 -
Technology Enabled Mental Health Intervention for Individuals in the Criminal Justice System
|
N/A | |
Completed |
NCT04075448 -
The Acute Effect of a Walnut Intervention on Cognitive Performance, Brain Activation, and Serum Markers of Inflammation in Young Adults
|
N/A |