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Trial registered on ANZCTR


Registration number
ACTRN12613000891729
Ethics application status
Approved
Date submitted
6/08/2013
Date registered
9/08/2013
Date last updated
21/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Vitamin D-enriched mushrooms, Vitamin D and mushroom controls on cognition and mood in older adults
Scientific title
Randomised clinical trial testing effects of Vitamin D-enriched mushroom, Vitamin D and mushroom controls on cognition and mood in a healthy aged population.
Secondary ID [1] 282982 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition 289808 0
Vitamin D deficiency 289810 0
Mood 289811 0
Condition category
Condition code
Mental Health 290158 290158 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 290172 290172 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to take one capsule of either of the following every day for 6 months:
1) Vitamin D-enriched Button mushroom solids (500 mg, including 600 IU of Vitamin D) in a cellulose carrier
2) 600 IU of Vitamin D in a cellulose carrier
3) Standard Button mushroom solids (500 mg) in a cellulose carrier
4) Placebo (cellulose carrier alone)

Participants will present to the CSIRO Clinic at baseline, 6 weeks and 6 months to donate a blood sample and undergo cognitive testing. In addition, a buccal cell scrape will be performed at baseline. Prior to presenting to the clinic at the nominated time points, participants will be asked to complete mail-out questionnaires.

Adherence will be monitored as follows: participants will be provided with a calendar to mark any days they forget to take a capsule and will be asked to return the capsule bottle (containing any remaining capsules) at the end of the intervention.
Intervention code [1] 287695 0
Prevention
Comparator / control treatment
Comparators:
1) Vitamin D-enriched Button mushroom solids
2) Vitamin D
3) Button mushroom solids

Control:
1) Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 290187 0
Cognitive Performance
1) Short-term memory: Word List (immediate and delayed recall)
2) Long-term Retrieval: Word endings
3) Working memory: Operation Span
4) Reasoning: Raven’s Progressive Matrices (abbreviated)
5) Perceptual Speed: Digit Symbol Substitution
6) Processing speed: simple reaction time, 2-choice-reaction time, reasoning speed, and memory scanning speed
7) Inhibition: Colour Stroop
Timepoint [1] 290187 0
Baseline, 6 weeks, 6 months
Primary outcome [2] 290188 0
Mood and depressive symptoms (mail-out questionnaires)
1) The Positive and Negative Affect Schedule – extended form
2) Centre for Epidemiology Studies Depression Scale
Timepoint [2] 290188 0
Baseline, 6 weeks, 6 months
Primary outcome [3] 290189 0
Plasma content of Amyloid Precursor Protein (APP)
Timepoint [3] 290189 0
Baseline, 6 weeks, 6 months
Secondary outcome [1] 304073 0
Plasma Vitamin D content
Timepoint [1] 304073 0
Baseline, 6 weeks, 6 months
Secondary outcome [2] 304074 0
Genotyping (buccal Scrape) of genes involved with Vitamin D metabolism (GC, DHCR7, CYP2R1), B group vitamins (folate and related co-factors) and inflammation (IL-6 and TNFa).
Timepoint [2] 304074 0
Baseline

Eligibility
Key inclusion criteria
1) Healthy adults 60-90 years of age
2) Fluency in the English language (for valid completion of the cognitive test battery)
3) Agree to not commence any other form of oral Vitamin D supplementation throughout the duration of the study
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Already taking Vitamin D supplements
2) Inability to swallow tablets
3) Physically unable to attend CSIRO cognitive laboratory/use a computer/pen and paper
4) Any of the following confounding factors affecting cognitive status: diagnosed with intellectual disability, dementia; untreated depression (identified at screening using the CES-D questionnaire; score > 16); score < 24 on the MMSE at screening, neurological disorder including but not limited to cerebral vascular disease, have had head injury, stroke, coronary artery bypass surgery, history of alcohol or drug abuse, metabolic disease including diabetes, untreated asthma, shift workers, people who habitually sleep < 6 hrs a night, or those with untreated obstructive sleep apnoea (identified at screening using OSA 50 questionnaire), untreated depression (unless taking SSRI medication and stabilised for >6 months), abnormal thyroid function (hypo, hyper), abnormal Vitamin B12 status, history of psychosis and/or taking anti-psychotic medication, history of epilepsy and/or taking anti-epileptic medication, prior significant head injury or neurosurgical procedure, past participation in the EPOCH Trial (ACTRN12607000278437)
5) Any of the following confounding factors affecting Vitamin D status: kidney disease or kidney function impairment; gastro-intestinal condition that interferes with nutrient absorption.

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)
Screening: Recruitment will proceed for 3-6 months prior to commencement of the study in order to achieve required participant numbers. Those meeting self-reportable inclusion criteria (by questionnaire responses) will be asked to attend CSIRO’s cognitive laboratory (Cog Lab) undertake the Mini-Mental State Examination (MMSE). The MMSE is a widely used and validated screening tool for dementia. Those scoring 24 or less, the traditional cut-off score for possible dementia, will be excluded. Those with acceptable MMSE test scoring will be asked to submit a blood sample for screening to select for normal levels of: HBA1c, thyroid stimulating hormone, kidney function using biochemical tests (MBA20) and Vitamin B12. Finally, those meeting self-reportable, cognitive and biochemical inclusion criteria will be included in the RCT.

Method of Allocation Concealment: Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
17/04/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
430
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 7257 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287755 0
Commercial sector/Industry
Name [1] 287755 0
Horticulture Australia Limited
Country [1] 287755 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Gate 13, Kintore Avenue, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 286477 0
None
Name [1] 286477 0
Address [1] 286477 0
Country [1] 286477 0
Other collaborator category [1] 277567 0
University
Name [1] 277567 0
University of Adelaide,
Address [1] 277567 0
The University of Adelaide, SA 5005
Country [1] 277567 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289700 0
CSIRO Animal, Food and Health Sciences Human Research Ethics Committee
Ethics committee address [1] 289700 0
Ethics committee country [1] 289700 0
Australia
Date submitted for ethics approval [1] 289700 0
Approval date [1] 289700 0
06/08/2013
Ethics approval number [1] 289700 0
13/05

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

Contacts
Principal investigator
Name 42042 0
Dr Louise Bennett
Address 42042 0
CSIRO Animal, Food and Health Sciences
Sneydes Road, Werribee, VIC 3030
Country 42042 0
Australia
Phone 42042 0
+61 3 9731 3318
Fax 42042 0
Email 42042 0
[email protected]
Contact person for public queries
Name 42043 0
Julia Weaver
Address 42043 0
CSIRO Animal, Food and Health Sciences
Gate 13 Kintore Avenue Adelaide, SA 5000
Country 42043 0
Australia
Phone 42043 0
+61 8 8303 8876
Fax 42043 0
Email 42043 0
[email protected]
Contact person for scientific queries
Name 42044 0
Vanessa Danthiir
Address 42044 0
CSIRO Animal, Food and Health Sciences
Gate 13 Kintore Avenue Adelaide, SA 5000
Country 42044 0
Australia
Phone 42044 0
+61 8 8305 0605
Fax 42044 0
Email 42044 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
SourceTitleYear of PublicationDOI
EmbaseThe effects of vitamin d-enriched mushrooms and vitamin d3 on cognitive performance and mood in healthy elderly adults: A randomised, double-blinded, placebo-controlled trial.2020https://dx.doi.org/10.3390/nu12123847
N.B. These documents automatically identified may not have been verified by the study sponsor.