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Study on Attention, Memory, & Eye Health in Teens
Volunteers aged 13 to 18 years are needed to examine the effects of a natural supplement on attention, memory and eye health
This is a registered clinical trial with the Australian and New Zealand Clinical Trials Registry
This study is only available for people able to travel to our office in Duncraig, WA 6023
Lutein and zeaxanthin (LZ) are fat-soluble antioxidant nutrients that are responsible for many of the colours found in plants and other foods. Lutein is found in dark green leafy vegetables like spinach and kale and in corn and egg yolks. Zeaxanthin is prominent in orange and yellow foods such as com, egg yolks, orange capsicums, persimmons, tangerines, mandarins, and oranges. In the body, LZ are found in the eye and brain and in several studies on adults, supplementation with LZ has been shown to positively affect eye health, attention, and memory. Therefore, in this study, we are investigating if it may have beneficial effects on teenagers.
If you are between 13 and 18 years old (up to 19 years old) and use electronic screens (i.e., computers, phones, tablets) more than 4 hours a day, we invite you to participate in this randomised, controlled study.
PLEASE NOTE:
- Travel to our office located in Duncraig is required on 3 occasions (baseline, month 3, and month 6)
- Consent is required from the participant/teen and parent / legal guardian (if the participant is under 18 years of age
This 6-month study consists of the following:
- Participate in a 10-minute phone interview to discuss the study.
- Attend a face-to-face assessment on 3 occasions (baseline, day 90, and day 180) at our Duncraig offices. Visits 1 and 3 will take 90 minutes, and visit 2 will take 45 minutes. During these visits, we will measure the participant's blood pressure, weight and height. A brief eye test will be conducted and several tasks assessing memory and attention will also be administered.
- Take the capsules for 6 months (1 capsule daily, containing either placebo or lutein/zeaxanthin)
- Complete online questionnaires every 4 weeks. This will take approximately 10 minutes. This will need to be completed by the participant/ teen and parent/guardian (if the participant is under 18 years).
You can download the full STUDY INFORMATION SHEET by clicking the button on this webpage
To be INCLUDED in the study, the following inclusion criteria must be met for the participant/teen:
- Aged 13 to 18 (i.e., before you turn 19 years)
- Eats a diet generally low in fruit and vegetables
- Uses light emitting diode (LED) screens (e.g., televisions, computer screens, mobile/phones, tablets) for more than 4hrs a day
- If attends school, must attend mainstream schooling and mainstream classes
- Has no plan to commence a new treatment over the study period which might affect the treatment outcomes.
- Is willing and able to swallow capsules
- The teen and parent/legal guardian of the teen (if under 18 years) are willing to provide personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
- Teen and parent/legal guardian of the teen (if under 18 years) are fluent in English
If any of the exclusion criteria below are met, the applicant will not be suitable for participation in this study:
- Is significantly over- or under-weight for his/her age
- Has been diagnosed with a learning disability
- Has a current or 12-month history of any significant psychiatric disorder (including ADHD)
- Has a current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes, or gastrointestinal disease
- Is currently taking pharmaceutical medications that might affect the treatment outcomes.
- Is regularly taking nutritional or herbal supplements that might affect the treatment outcomes.
- Is experiencing exceptional social/family stressors (e.g., serious illness in the family, recent parental separation, etc).
- Has plans for major lifestyle changes in the next 6 months.
- Is a regular nicotine smoker or vaper
- Currently (or in the last 12 months) has used illicit drugs
- Consumes more than 14 standard drinks of alcohol a week
- Is pregnant, breastfeeding, or intends to fall pregnant during the study period.
- Has had a major surgery over the last year or has a planned major surgery during the study period
- Has participated in any other clinical trial in the last month
To compensate you for your time and travel costs we will provide the following:
- A $40 gift voucher at visit 1
- A $40 gift voucher at visit 2
- A $100 gift voucher at visit 3
- As we will be using validated measures to test memory and cognitive performance we will provide a report at the end of the study that provides details about how the participant performs against similar-aged peers.
This study has been approved by the National Institute of Integrative Medicine (NIIM) Ethics Committee (Reference number: 0145E_2024)
If you are interested in participating in this study, please click on the button "Complete the Study Application Form" located on this webpage. This questionnaire will take aproximately 5 to 10 minutes to complete and helps us assess your eligibility to participate in this study.
Please Note: All answers are confidential and will only be seen by study investigators. If you are not eligible to participate in this study, your records will be deleted immediately
If you would like to speak to a researcher to get more information about this study, you can call us on 08 9448 7376
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