None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 90 adults with self-reported cognitive complaints will be randomly assigned to receive capsules containing either a Lutein/Zeaxanthin combination (10mg Lutein and 2mg Zeaxanthin, once daily) or a placebo for 180 days. 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.
Interventions
Condition 1: Placebo capsules (1 capsule taken orally, once daily with dinner for 180 days)
Condition 2: Lutein and Zeaxanthin (1 capsule taken orally, once daily with dinner, delivering 10mg Lutein and 2mg Zeaxanthin a day, for 180 days)
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
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Healthy adults (male and female) between 40 and 75 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. Non-smoker 5. BMI between 18 and 35 kg/m2 6. No plan to commence new treatments over the study period 7. Understand, willing and able to comply with all study procedures 8. 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. A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M) 3. Suffering from recently diagnosed 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 4. 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 5. History of stroke or seizures or head injury (with loss of consciousness). 6. Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, or steroid medications. 7. Change in medication in the last 3 months or expectation to change during the study duration 8. Current nutrient deficiencies including low iron or vitamin B12 concentrations 9. Taking vitamins or herbal supplements that are reasonably expected to influence study measures. 10. Current or 12-month history of illicit drug abuse 11. Alcohol intake greater than 14 standard drinks per week 12. Any significant surgeries over the last year
Outcome results
None listed