None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 teenagers aged 13 to 18 years, eating a diet low in fruit and vegetables and using light emitting diode (LED) screens for more than 4 hours will be randomly assigned to receive capsules containing either Lute-gen (Lutein 10 mg & Zeaxanthin-isomers 2mg) daily or a placebo for 6 months. Changes in macular pigment optical densitiy, visual memory, processing speed, attention, and sleep will be assessed over time by administering several researcher-administered assessments and participants completing validated self-report questionnaires.
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
13 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy (male and female) aged between 13 to 18 years (13 years to less than 19 years old) 2. Eats a diet generally low in fruit and vegetables as measured by a score less than or equal to 11 on the Block Rapid Fruit and Vegetable Intake Screener 3. Uses light emitting diode (LED) screens (e.g., televisions, computer screens, mobile/phones, tablets) for more than 4hrs a day 4. If attends school, attends mainstream schooling and mainstream classes 5. BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, sex, and height. 6. Has no plan to commence a new treatment over the study period which might affect the treatment outcomes. 7. 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. 8. Willing and able to swallow capsules 9. Teen and parent/legal guardian of the teen (if under 18 years) are fluent in English
Exclusion criteria
1. Has a diagnosed learning disability 2. Has a current or 12-month history of any significant psychiatric disorder (including attention deficit hyperactivity disorder) 3. Has a current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes, or gastrointestinal disease 4. Is currently taking pharmaceutical medications that might affect the treatment outcomes. 5. Is regularly taking nutritional or herbal supplements that might affect the treatment outcomes. 6. Is experiencing exceptional social/family stressors (e.g., serious illness in the family, recent parental separation, etc). 7. Has plans for major lifestyle changes in the next 6 months. 8. Is a regular nicotine smoker or vaper 9. Currently (or in the last 12 months) has used illicit drugs 10. Consumes more than 14 standard drinks of alcohol a week 11. Is pregnant, breastfeeding, or intends to fall pregnant during the study period. 12. Has had a major surgery over the last year or has a planned major surgery during the study period 13. Has participated in any other clinical trial in the last month
Outcome results
None listed