This site is now managed by the Commonwealth Department of Health and Aged Care. 

Australian Clinical Trials

Clinical Trial Details

Food for Thought: Assessing the effect of diet and dietary advice on cognitive function in older people at risk

Print record Print record
Trial Information

Broad Health Condition Neurological

Specific Health ConditionNeurodegenerative diseases

Trial FocusTreatment

Recruitment Details

Recruitment status
Not yet recruiting

Recruitment State
NSW

Hospital

Postcode
2500 - Wollongong
1466 - Unsw Sydney

Anticipated date of first participant enrolment2/09/2022

Anticipated date of last participant enrolment8/09/2023

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

We propose a world-first dietary intervention clinical trial to investigate whether anthocyanins can sustainably delay or prevent memory loss progression in people at high risk for dementia. Anthocyanins (which provide deep-red and purple-blue pigmentation in plants and fruits) show promise for their pro-cognitive effects and therapeutic potential for diseases that manifest cognitive impairment. Our clinical trials have already demonstrated that consumption of anthocyanin-rich fruit significantly improves both short- and long-term memory, and verbal fluency in older adults with mild to moderate Alzheimer’s dementia (AD) and mixed dementia. However, it is unknown whether anthocyanins can prevent the progression of cognitive decline in persons with mild cognitive impairment. The findings of this study will be critical to underpin dietary advice that better informs prevention of dementia in Australia and allow translation to dietary advice on plant-based foods for better brain health

Eligibility

Key inclusion criteria

1) a) Diagnosis of amnestic MCI (single or multidomain) by a geriatrician, neuropsychiatrist or neuropsychologist; b) or be deemed as eligible by achieving a score equivalent to MCI status following completion of the  Montreal Cognitive Assessment (T-MoCa) screening test administered via a  validated telephone interview tool. A person scoring 13 or less on the Memory Index Score (MIS) within the T-MoCA will be considered to the study.
2) Self-reported subjective memory complaints
3) English-speaking; 
4) Aged 60 - 85 y; 
5) Able to complete all or all but one of the following basic activities of daily living (unless for physical reason, e.g. arthritis, poor vision): ‘Do you need help to manage everyday activities such as: Personal hygiene?; Dressing?; Taking medication?; Shopping and preparing food?; Transport?; Telephoning?; Finances?; Housekeeping?

Minimum age60 Years

Maximum age85 Years

GenderBoth males and females

Can Healthy volunteers participate? No

Key exclusion criteria

1) Non-English speaking; 
2) History of psychiatric (other than mood) disorder in the past 5 y; 
3) Underlying additional neurodegenerative condition such as Parkinson’s disease; 
4) Other significant neurological history including head injury, epilepsy, or tumour. 
5) Taking any of the following medications: donepezil, galantamine, rivastigmine or memantine
6) Scoring 11 or less at the overall T-MoCA or have been diagnosed with Alzheimer’s disease or any other dementia


Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Wollongong
Primary Sponsor Address: Northfields Ave, Wollongong NSW 2522
Primary Sponsor Country: Australia

Trial IDACTRN12622000065796

Contact person for information and recruitmentDr
Vinicius do Rosario
Northfields Ave, University of Wollongong NSW 2522 Building 41
+61 2 0414054123

Email contact Further information iconvinicius@uow.edu.au

Australia