Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000624088
Ethics application status
Approved
Date submitted
29/07/2010
Date registered
30/07/2010
Date last updated
15/07/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive and mood effects of saccharides in middle-aged adults
Scientific title
Effects of saccharides on high demand cognitive performance and psychological well-being in healthy, middle-aged Australian adults between 45 and 60 years of age.
Secondary ID [1] 252343 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive performance and mood 257845 0
Condition category
Condition code
Mental Health 258010 258010 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Volunteers will consume a 2g dose, twice daily of a patented, commerically available blend of plant polysaccharides daily for 12 weeks ( total consumption of 4g per day). This dietary supplement will be delivered orally in powdered form, to be taken with juice or water. Participants will have two separate assessments of cognitive performance (of 3.5 hours each) through 2 visits at the research centre. The visits will be 12 weeks apart. Following the baseline visit participants will be randomised to consume a placebo or a 4g dose of saccharides for 12 weeks. At each baseline and post-intervention visit, participants will complete tasks of cognition and mood, assessing attention, concentration, memory and learning, as well as general mood (mood states including: mental fatigue, anxiety, relaxed, tense, outlook and overall mood).
At each visit, participants will provide a finger capillary measure of blood glucose in response to same day administration of intervention (day 1 and day 84).
Intervention code [1] 256901 0
Lifestyle
Intervention code [2] 256907 0
Treatment: Other
Intervention code [3] 256908 0
Other interventions
Comparator / control treatment
Volunteers will consume a 2g dose, twice daily of placebo (control treatment) daily for 12 weeks (total consumption of 4g per day). This supplement will be delivered orally in powdered form, to be taken with juice or water. The placebo supplement is identical in appearance, texture and taste only without the active ingredient. Participants will have two separate assessment of cognitive performance at two visits (of 3.5 hours each) to the research centre. The visits will be 12 weeks apart. Following the baseline visit participants will be randomised to consume a placebo or a 4g dose of saccharides for 12 weeks. At each baseline and post-intervention visit, participants will complete tasks of cognition and mood, assessing attention, concentration, memory and learning, as well as general mood (mood states including: mental fatigue, anxiety, relaxed, tense, outlook and overall mood). At each visit, participants will provide a finger capillary measure of blood glucose in response to same day administration of intervention (day 1 and day 84).
Control group
Placebo

Outcomes
Primary outcome [1] 258868 0
Degree of change in overal mean cognitive performance assessed by administration of a cognitively demanding series of tasks on a computerised battery.
Timepoint [1] 258868 0
At Baseline (day 1) and post intervention assessment (week 12, day 84)
Primary outcome [2] 258869 0
Degree of change in mean memory performance on immediate, delayed and recognition memory as assessed by the Rey Auditory Verbal Learning Task.
Timepoint [2] 258869 0
At baseline ( day 1) and post intervention (week 12, day 84)
Secondary outcome [1] 264994 0
Degree of change in overall mood using Profile of Mood States, including tension, anger, vitality, anxiety and overall outlook.
Timepoint [1] 264994 0
At baseline ( day 1) and post intervention (week 12, day 84)
Secondary outcome [2] 264996 0
Degree of change in mood assessed using visual analogue scales of mood states including mental fatigue and anxiety
Timepoint [2] 264996 0
At baseline ( day 1) and post intervention (week 12, day 84)
Secondary outcome [3] 265001 0
Degree of blood glucose response to same day administration assessed by finger capillary blood glucose measurement.
Timepoint [3] 265001 0
At baseline (day 1) and post intervention (week 12, day 84)

Eligibility
Key inclusion criteria
Proficient in English
Healthy adults, male and female
Minimum age
45 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have had major heart surgery or cardiovascular disease,
diabetes, history of serious head injury, taking medications for head/brain injury or neurological conditions ( ie., stroke), history of, taking medications for serious psychiatric conditions

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257358 0
Commercial sector/Industry
Name [1] 257358 0
Mannatech Incorporated
Country [1] 257358 0
United States of America
Primary sponsor type
Individual
Name
Dr Talitha Best
Address
Nutritional Physiology Research Centre
University of South Australia PO Box 2471
Adelaide, South Australia, 5001
Country
Australia
Secondary sponsor category [1] 256598 0
Individual
Name [1] 256598 0
Professor Peter Howe
Address [1] 256598 0
Nutritional Physiology Research Centre
University of South Australia PO Box 2471
Adelaide, South Australia, 5001
Country [1] 256598 0
Australia
Secondary sponsor category [2] 256599 0
Individual
Name [2] 256599 0
Dr Janet Bryan
Address [2] 256599 0
School of Psychology, Social Work and Social Policy
University of South Australia PO Box 2471
Adelaide, South Australia, 5001
Country [2] 256599 0
Australia
Other collaborator category [1] 251408 0
Individual
Name [1] 251408 0
Professor Andrew Scholey
Address [1] 251408 0
Brain Sciences Institute
Swinburne University
400 Burwood Rd
Hawthorn VIC 3122
Country [1] 251408 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259378 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 259378 0
Ethics committee country [1] 259378 0
Australia
Date submitted for ethics approval [1] 259378 0
Approval date [1] 259378 0
27/07/2010
Ethics approval number [1] 259378 0
P052/10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31448 0
Address 31448 0
Country 31448 0
Phone 31448 0
Fax 31448 0
Email 31448 0
Contact person for public queries
Name 14695 0
Dr Talitha Best
Address 14695 0
Nutritional Physiology Research Centre
University of South Australia
PO Box 2471
Adelaide, South Australia 5001
Country 14695 0
Australia
Phone 14695 0
+61 8 8302 2287
Fax 14695 0
Email 14695 0
[email protected]
Contact person for scientific queries
Name 5623 0
Dr Talitha Best
Address 5623 0
Nutritional Physiology Research Centre
University of South Australia
PO Box 2471
Adelaide, South Australia 5001
Country 5623 0
Australia
Phone 5623 0
+61 8 8302 2287
Fax 5623 0
Email 5623 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.