The effects of Lutein/Zeaxanthin supplementation on cognitive function in adults with self-reported mild cognitive complaints

Not Applicable

Completed

• 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: ACTRN12621000038897
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-18
• Study Completion: 2021-10-27
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)[Day 0 and 180]

Secondary Outcome Measures

Name	Time	Method
Change in cognitive skills as measured by the Cognitive Failures Questionnaire (CFQ)[Day 0 (pre-intervention), 30, 60, 90, 120, 150, and 180 post-intervention];Change in Behavior Rating Inventory of Executive Function – Adult Version (BRIEF-A)[Day 0 (pre-intervention), 60, 120 and 180 post-intervention];Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29): [Day 0 (pre-intervention), 30, 60, 90, 120, 150, and 180 post-intervention];Change in Profile of Mood States, abbreviated version (POMS): [Day 0 (pre-intervention), 30, 60, 90, 120, 150, and 180 post-intervention]