None listed
Conditions
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.
Interventions
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Healthy volunteers
No
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
Outcome results
None listed