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

Not Applicable

Active, not recruiting

• Conditions: Mild Cognitive Impairment; Neurological - Other neurological disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine; Mental Health - Other mental health disorders

• Registration Number: ACTRN12621000496819
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-29
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 143

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.

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

• Study Type: Interventional
• Study Design: Not specified