Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000496819
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
29/04/2021
Date last updated
28/03/2022
Date data sharing statement initially provided
29/04/2021
Date results information initially provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a polyphenol-rich grape and blueberry extract (Memophenol) on cognitive function in older adults with mild cognitive impairment: a randomised, double-blind, placebo-controlled study
Scientific title
Effects of a polyphenol-rich grape and blueberry extract on cognitive function in older adults with mild cognitive impairment
Secondary ID [1] 303794 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 321303 0
Condition category
Condition code
Neurological 319085 319085 0 0
Other neurological disorders
Alternative and Complementary Medicine 319086 319086 0 0
Other alternative and complementary medicine
Mental Health 319087 319087 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: Placebo capsules (1 capsule taken orally, twice daily with breakfast and dinner for 24 weeks)

Condition 2: Grape and blueberry extract (Memophenol) (1 capsule taken orally, twice daily with breakfast and dinner, delivering 300 mg a day for 24 weeks)

Adherence to capsule intake will be monitored through a mobile phone app and capsule return and count.
Intervention code [1] 320099 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing maltodextrin) is matched to the grape/blueberry extract capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 326971 0
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [1] 326971 0
Day 0, week 12, & week 24 (primary endpoint) post-intervention commencement
Secondary outcome [1] 393318 0
Change in Cognitive Failures Questionnaire (CFQ)
Timepoint [1] 393318 0
Day 0, weeks 4, 8, 12, 16, 20, & 24 post-intervention commencement
Secondary outcome [2] 393319 0
Change in Profile of Mood States, Abbreviated Version (POMS-A)
Timepoint [2] 393319 0
Day 0, weeks 4, 8, 12, 16, 20, & 24 post-intervention commencement
Secondary outcome [3] 393320 0
Change in Control, Autonomy, Self-Realization and Pleasure (CASP-19)
Timepoint [3] 393320 0
Day 0, weeks 4, 8, 12, 16, 20, & 24 post-intervention commencement
Secondary outcome [4] 393321 0
Change in Behavior Rating Inventory of Executive Function – Adult Version (BRIEF-A)
Timepoint [4] 393321 0
Day 0, week 12 & 24 post-intervention commencement
Secondary outcome [5] 393322 0
Change in urinary concentrations of specific metabolites from the phenolic compounds
Timepoint [5] 393322 0
Day 0, week 12 & 24 post-intervention commencement
Secondary outcome [6] 394428 0
Change in plasma concentrations of specific metabolites from the phenolic compounds
Timepoint [6] 394428 0
Day 0, week 12 & 24 post-intervention commencement

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) 60 to 80 years
2. Residing in independent living accommodation
3. Subjective report of memory or attention problems by answering ‘yes’ to the following question: Do you have problems with your memory, attention, or concentration?
4. A score of between 13 and 18 on the telephone administered Montreal Cognitive Assessment – Blind Version (MoCA-BV)
5. Non-smoker
6. BMI between 18 and 30 kg/m2
7. No plan to commence new treatments over the study period
8. Understand, willing and able to comply with all study procedures
9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria
2. Suffering from recently diagnosed (within 3 months), or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition
3. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), or cancer/malignancy
4. A score greater than 5 on the Geriatric Depression Scale, Short Form (GDS-SF) and/or a score greater than 7 on the Patient Health Questionnaire – 4 (PHQ-4)
5. History of stroke or seizures or head injury (with loss of consciousness).
6. Regular medication intake including but not limited to anticoagulants, blood thinners and anti-hypertensive drugs, anticholinergics, acetylcholinesterase inhibitors, or steroid medications.
7. Change in medication in the last 3 months or expectation to change during the study duration
8. Reported nutrient deficiencies including low iron or vitamin B12
9. Taking vitamins, herbal, or omega-3 supplements that are reasonably expected to influence study measures.
10. People with fragile veins and past difficulty in giving blood.
11. Current or 12-month history of illicit drug abuse
12. Alcohol intake greater than 14 standard drinks per week
13. Any significant surgeries over the last year
14. Planned major lifestyle change in the next 6 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 14 randomly permuted blocks, containing 10 participants per block.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on a previous study on Memophenol, we are predicting an effect size of 0.5 compared to placebo. Based on this, a sample size of 64 per group is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 70 participants per group (140 participants in total), which should give us a suitable power to find an effect, even after dropouts.

Pre and post analyses will be conducted to determine changes in the following:

1. Computerised Mental Performance Assessment System (COMPASS)
2. Profile of Mood States, abbreviated version (POMS-A)
3. Control, Autonomy, Self-Realization and Pleasure (CASP-19)
4. Cognitive Failures Questionnaire (CFQ)
5. Behavior Rating Inventory of Executive Function – Adult Version (BRIEF-A)
6. Urinary and plasma concentrations of specific metabolites from the phenolic compounds from Memophenol
7. Correlation between change in cognitive scores and changes in plasma and urinary metabolites

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/05/2021
Actual
8/06/2021
Date of last participant enrolment
Anticipated
26/11/2021
Actual
20/12/2021
Date of last data collection
Anticipated
8/07/2022
Actual
Sample size
Target
140
Accrual to date
Final
143
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 308197 0
Commercial sector/Industry
Name [1] 308197 0
Activ’Inside
Country [1] 308197 0
France
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Road Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 308976 0
None
Name [1] 308976 0
Address [1] 308976 0
Country [1] 308976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308178 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 308178 0
11-23 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 308178 0
Australia
Date submitted for ethics approval [1] 308178 0
02/02/2021
Approval date [1] 308178 0
29/03/2021
Ethics approval number [1] 308178 0
0085E_2021

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 140 adults with self-reported cognitive complaints will be randomly assigned to receive capsules containing either a Grape/Blueberry extract (150mg twice daily) or a placebo for 24 weeks. A computer-based assessment and several validated clinician-administered and self-report measures (to be completed at various time points throughout the study) will be administered to assess change in cognitive performance, mood, and quality of life. Changes in urinary and plasma concentrations of specific metabolites from the phenolic compounds from Grape/Blueberry extract will also be examined.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109818 0
Dr Adrian Lopresti
Address 109818 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 109818 0
Australia
Phone 109818 0
+61 08 94487376
Fax 109818 0
Email 109818 0
[email protected]
Contact person for public queries
Name 109819 0
Dr Adrian Lopresti
Address 109819 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 109819 0
Australia
Phone 109819 0
+61 08 94487376
Fax 109819 0
Email 109819 0
[email protected]
Contact person for scientific queries
Name 109820 0
Dr Adrian Lopresti
Address 109820 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 109820 0
Australia
Phone 109820 0
+61 08 94487376
Fax 109820 0
Email 109820 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.