Lutein and Zeaxanthin Dietary IntakeNCT04779411
Online Validation of Dietary Intake Food Frequency Questionnaire Over Four Weeks, and Electronic Device Use Questionnaire Over Eight Weeks.
An observational study of Lutein and Zeaxanthin Dietary Intake and Age Related Macular Degeneration, run by The University of Queensland at 1 site in Australia.
Trial summary
Tools to investigate dietary lutein and zeaxanthin (L/Z) intake and electronic device (ED) use are important to progress research that investigates the role of ED blue light (BL) exposure, and dietary L/Z intake on macular health. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lutein and Zeaxanthin Dietary Intake, Age Related Macular Degeneration, Blue Light Exposure
- What is being tested?
- Weekly Food Frequency Questionnaire, Monthly Food Frequency Questionnaire and 24-Hour Diet Recall
- How many people
- 183 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Aug 2020to 1 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Generally healthy male and female adults from Australia or the United Kingdom.
Who may be able to join
- Healthy males and females 18 years and over.
- Access to an ED such as a computer, phone, or tablet, and internet to complete investigations.
Who cannot join
- Visual, hearing, or physical impairment that may prevent from completing investigations.
- No English literacy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Lutein and Zeaxanthin Food Frequency Questionnaire, and an Electronic Device Use Questionnaire.
Tools to investigate dietary lutein and zeaxanthin (L/Z) intake and electronic device (ED) use are important to progress research that investigates the role of ED blue light (BL) exposure, and dietary L/Z intake on macular health. This project aims to validate two questionnaires developed by our research group: The L/Z FFQ, and the Electronic Device Use Questionnaire (EDUQ). The L/Z FFQ aims to investigate dietary intake of L/Z over the prior week or month. The EDUQ aims to investigate usual hours and behaviours surrounding ED use over the prior three months.
This aims of this project are to:
- Validate a L/Z FFQ recalling over a weekly and monthly timeframe against multiple 24-hour diet recalls over four weeks.
- Validate the EDUQ against multiple 24-hour ED use diaries over eight weeks. A cohort of 100 adults will be invited to participate to validate the FFQ and EDUQ. Participants will be offered to choose to participate in one or both the questionnaire validations (L/Z FFQ and EDUQ).
Read the detailed description
L/Z FFQ Validation The validation procedure will span over four weeks, consisting of administering the L/Z FFQ and 24-hour diet recalls at multiple timepoints. Timepoints for the eight 24-hour diet recalls will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on week days.
- The weekly L/Z FFQ will be completed at the conclusion of each of the four weeks.
- The monthly L/Z FFQ will be completed at baseline and at the conclusion of week four.
Participants will indicate their consent to participate on Checkbox® by proceeding to the complete the questionnaires.
- Demographic information: at the beginning of the first investigation (monthly L/Z FFQ) participants will be asked to report their weight, height, age, gender, highest level of education, occupational status (employed or unemployed), post-code and country of residence, usual hours of physical activity per week, how they heard about the study, and whether they are actively trying to gain or lose weight. Personal information is to be collected to qualify the characteristics of the population in which the tool is being validated. Data collected via Checkbox ®.
- L/Z FFQ: The weekly L/Z FFQ is a 91-item questionnaire that takes approximately 20 minutes to complete, and investigates the frequency of intake of listed foods or supplements over the prior seven days. The monthly L/Z FFQ contains the same 91 items, takes approximately 30 minutes to complete, and investigates the frequency of intake of listed foods or supplements over the prior month. In addition, the monthly L/Z FFQ contains four qualitative questions that investigate change in usual dietary intake over the last one to ten years. Questionnaire data collected via Checkbox®.
- 24-hour diet recall: the diet recall via the online Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24®) takes approximately 25 minutes to complete, and investigates food and beverages consumed in the prior 24-hours (20). The ASA24® is supported by the National Institutes of Health (NIH) in the United States (US) with national variants and as a US government entity not within the EU-US Data Privacy Shield for legal reasons. Therefore, explicit consent for use of the ASA24® tool will be sought from participants. For further information on the tool: https://epi.grants.cancer.gov/asa24/.
EDUQ Validation
The validation procedure will occur over eight weeks consisting of administering eight 24-hour diary of ED use (24-hour ED use diary) and the EDUQ at three time points. The time points for the eight 24-hour ED use diaries will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on weekdays. The EDUQ will be completed at baseline and at the conclusion of weeks four and eight. Upon consenting to participate on the Checkbox® by proceeding to the questionnaires, participants will be instructed to fill out:
- The EDUQ: A 22-item questionnaire that takes 20 minutes to complete, and measures participant demographic information (weight, height, age, highest level of education, occupational status, post-code and country of residence), usual daily ED use from present up to 20 years ago, occupational influence to use, and differences to ED use between a weekend and weekday (questionnaire adapted from Williams et al. (2019) (21). Personal information collected as part of this questionnaire is to qualify the characteristics of the population in which the tool is being validated. Data collected via Checkbox®.
- 24-hour ED use diary: Participants will be asked to record their ED use in hours and minutes over 24 hours. Data collected via Checkbox®.
- Conditions
- Lutein and Zeaxanthin Dietary Intake, Age Related Macular Degeneration, Blue Light Exposure, Electronic Device Use
- Being tested
- Weekly Food Frequency Questionnaire, Monthly Food Frequency Questionnaire, 24-Hour Diet Recall, Electronic Device Use Questionnaire, 24-Hour Electronic Device Use Diary
- Keywords
- Lutein, Zeaxanthin, Food Frequency Questionnaire, Blue Light, Electronic Device Use
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly Food Frequency QuestionnaireOther
A purpose designed 91-item questionnaire to measure frequency of consumption of a selection of L/Z containing foods over the prior 7 days.
Monthly Food Frequency QuestionnaireOther
A purpose designed 95-item questionnaire completed at visit 1 to measure frequency of consumption of a selection of L/Z containing foods over the prior month.
24-Hour Diet RecallOther
the diet recall via the online Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24®) takes approximately 25 minutes to complete, and investigates food and beverages consumed in the prior 24-hours.
Electronic Device Use QuestionnaireOther
- The EDUQ: A 22-item questionnaire that takes 20 minutes to complete, and measures participant demographic information (weight, height, age, highest level of education, occupational status, post-code and country of residence), usual daily ED use from present up to 20 years ago, occupational influence to use, and differences to ED use between a weekend and weekday.
24-Hour Electronic Device Use DiaryOther
Participants asked to record their electronic device use in hours and minutes over 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Food Frequency Questionnaire Validation Group | The validation procedure will span over four weeks, consisting of administering the Lutein and Zeaxanthin Food Frequency Questionnaire (FFQ L/Z) and 24-hour diet recalls at multiple timepoints. Timepoints for the eight 24-hour diet recalls will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on week days.
* The weekly L/Z FFQ will be completed at the conclusion of each of the four weeks.
* The monthly L/Z FFQ will be completed at baseline and at the conclusion of week four. Receives: Other: Weekly Food Frequency Questionnaire; Other: Monthly Food Frequency Questionnaire; Other: 24-Hour Diet Recall | |
| Electronic Device Use Questionnaire Validation Group | The validation procedure will occur over eight weeks consisting of administering eight 24-hour diary of electronic device use (24-hour ED use diary) and the Electronic Device Use Questionnaire (EDUQ) at three time points. The time points for the eight 24-hour ED use diaries will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on weekdays. The EDUQ will be completed at baseline and at the conclusion of weeks four and eight. Receives: Other: Electronic Device Use Questionnaire; Other: 24-Hour Electronic Device Use Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Intake of lutein and zeaxanthin
Calculation from each dietary intake tool what the daily milligrams of lutein and zeaxanthin intake is.
Measured: 4 weeks
Daily hours of electronic device use.
Calculation from the two device use recording tools what the daily hours of electronic device use is for each participant.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start18 Aug 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Lutein and Zeaxanthin Dietary IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779411
- Sponsor's protocol ID
- FFQEDUQ20V1
- Status last verified
- May 2022
- First submitted
- 26 Feb 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keel S, Xie J, Foreman J, van Wijngaarden P, Taylor HR, Dirani M. Prevalence of Age-Related Macular Degeneration in Australia: The Australian National Eye Health Survey. JAMA Ophthalmol. 2017 Nov 1;135(11):1242-1249. doi: 10.1001/jamaophthalmol.2017.4182.
PubMed 29049463Bernstein PS, Li B, Vachali PP, Gorusupudi A, Shyam R, Henriksen BS, Nolan JM. Lutein, zeaxanthin, and meso-zeaxanthin: The basic and clinical science underlying carotenoid-based nutritional interventions against ocular disease. Prog Retin Eye Res. 2016 Jan;50:34-66. doi: 10.1016/j.preteyeres.2015.10.003. Epub 2015 Nov 2.
PubMed 26541886Velilla S, Garcia-Medina JJ, Garcia-Layana A, Dolz-Marco R, Pons-Vazquez S, Pinazo-Duran MD, Gomez-Ulla F, Arevalo JF, Diaz-Llopis M, Gallego-Pinazo R. Smoking and age-related macular degeneration: review and update. J Ophthalmol. 2013;2013:895147. doi: 10.1155/2013/895147. Epub 2013 Dec 4.
PubMed 24368940Chiu CJ, Chang ML, Zhang FF, Li T, Gensler G, Schleicher M, Taylor A. The relationship of major American dietary patterns to age-related macular degeneration. Am J Ophthalmol. 2014 Jul;158(1):118-127.e1. doi: 10.1016/j.ajo.2014.04.016. Epub 2014 Apr 29.
PubMed 24792100Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. doi: 10.1016/j.survophthal.2006.06.009.
PubMed 16950247Algvere PV, Marshall J, Seregard S. Age-related maculopathy and the impact of blue light hazard. Acta Ophthalmol Scand. 2006 Feb;84(1):4-15. doi: 10.1111/j.1600-0420.2005.00627.x.
PubMed 16445433Behar-Cohen F, Martinsons C, Vienot F, Zissis G, Barlier-Salsi A, Cesarini JP, Enouf O, Garcia M, Picaud S, Attia D. Light-emitting diodes (LED) for domestic lighting: any risks for the eye? Prog Retin Eye Res. 2011 Jul;30(4):239-57. doi: 10.1016/j.preteyeres.2011.04.002. Epub 2011 May 14.
PubMed 21600300Widomska J, Subczynski WK. Why has Nature Chosen Lutein and Zeaxanthin to Protect the Retina? J Clin Exp Ophthalmol. 2014 Feb 21;5(1):326. doi: 10.4172/2155-9570.1000326.
PubMed 24883226Liu T, Liu WH, Zhao JS, Meng FZ, Wang H. Lutein protects against beta-amyloid peptide-induced oxidative stress in cerebrovascular endothelial cells through modulation of Nrf-2 and NF-kappab. Cell Biol Toxicol. 2017 Feb;33(1):57-67. doi: 10.1007/s10565-016-9360-y. Epub 2016 Nov 22.
PubMed 27878403Frede K, Ebert F, Kipp AP, Schwerdtle T, Baldermann S. Lutein Activates the Transcription Factor Nrf2 in Human Retinal Pigment Epithelial Cells. J Agric Food Chem. 2017 Jul 26;65(29):5944-5952. doi: 10.1021/acs.jafc.7b01929. Epub 2017 Jul 13.
PubMed 28665123Satia JA, Watters JL, Galanko JA. Validation of an antioxidant nutrient questionnaire in whites and African Americans. J Am Diet Assoc. 2009 Mar;109(3):502-8, 508.e1-6. doi: 10.1016/j.jada.2008.11.033.
PubMed 19248870Romieu I, Parra S, Hernandez JF, Madrigal H, Willett W, Hernandez M. Questionnaire assessment of antioxidants and retinol intakes in Mexican women. Arch Med Res. 1999 May-Jun;30(3):224-39. doi: 10.1016/s0188-0128(99)00017-2.
PubMed 10427874McNaughton SA, Marks GC, Gaffney P, Williams G, Green A. Validation of a food-frequency questionnaire assessment of carotenoid and vitamin E intake using weighed food records and plasma biomarkers: the method of triads model. Eur J Clin Nutr. 2005 Feb;59(2):211-8. doi: 10.1038/sj.ejcn.1602060.
PubMed 15483635Stringham JM, Stringham NT, O'Brien KJ. Macular Carotenoid Supplementation Improves Visual Performance, Sleep Quality, and Adverse Physical Symptoms in Those with High Screen Time Exposure. Foods. 2017 Jun 29;6(7):47. doi: 10.3390/foods6070047.
PubMed 28661438Cartmel B, Moon TE. Comparison of two physical activity questionnaires, with a diary, for assessing physical activity in an elderly population. J Clin Epidemiol. 1992 Aug;45(8):877-83. doi: 10.1016/0895-4356(92)90071-t.
PubMed 1624970
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Lutein and Zeaxanthin Food Frequency Questionnaire, and an Electronic Device Use Questionnaire.
- ClinicalTrials.gov ID
- NCT04779411
- Acronym / sponsor ID
- FFQEDUQ20V1
- Conditions
- Lutein and Zeaxanthin Dietary Intake, Age Related Macular Degeneration, Blue Light Exposure, Electronic Device Use
- Keywords
- Lutein, Zeaxanthin, Food Frequency Questionnaire, Blue Light, Electronic Device Use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tools to investigate dietary lutein and zeaxanthin (L/Z) intake and electronic device (ED) use are important to progress research that investigates the role of ED blue light (BL) exposure, and dietary L/Z intake on macular health. This project aims to validate two questionnaires developed by our research group: The L/Z FFQ, and the Electronic Device Use Questionnaire (EDUQ). The L/Z FFQ aims to investigate dietary intake of L/Z over the prior week or month. The EDUQ aims to investigate usual hours and behaviours surrounding ED use over the prior three months.
This aims of this project are to:
- Validate a L/Z FFQ recalling over a weekly and monthly timeframe against multiple 24-hour diet recalls over four weeks.
- Validate the EDUQ against multiple 24-hour ED use diaries over eight weeks. A cohort of 100 adults will be invited to participate to validate the FFQ and EDUQ. Participants will be offered to choose to participate in one or both the questionnaire validations (L/Z FFQ and EDUQ).
Detailed description
L/Z FFQ Validation The validation procedure will span over four weeks, consisting of administering the L/Z FFQ and 24-hour diet recalls at multiple timepoints. Timepoints for the eight 24-hour diet recalls will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on week days.
- The weekly L/Z FFQ will be completed at the conclusion of each of the four weeks.
- The monthly L/Z FFQ will be completed at baseline and at the conclusion of week four.
Participants will indicate their consent to participate on Checkbox® by proceeding to the complete the questionnaires.
- Demographic information: at the beginning of the first investigation (monthly L/Z FFQ) participants will be asked to report their weight, height, age, gender, highest level of education, occupational status (employed or unemployed), post-code and country of residence, usual hours of physical activity per week, how they heard about the study, and whether they are actively trying to gain or lose weight. Personal information is to be collected to qualify the characteristics of the population in which the tool is being validated. Data collected via Checkbox ®.
- L/Z FFQ: The weekly L/Z FFQ is a 91-item questionnaire that takes approximately 20 minutes to complete, and investigates the frequency of intake of listed foods or supplements over the prior seven days. The monthly L/Z FFQ contains the same 91 items, takes approximately 30 minutes to complete, and investigates the frequency of intake of listed foods or supplements over the prior month. In addition, the monthly L/Z FFQ contains four qualitative questions that investigate change in usual dietary intake over the last one to ten years. Questionnaire data collected via Checkbox®.
- 24-hour diet recall: the diet recall via the online Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24®) takes approximately 25 minutes to complete, and investigates food and beverages consumed in the prior 24-hours (20). The ASA24® is supported by the National Institutes of Health (NIH) in the United States (US) with national variants and as a US government entity not within the EU-US Data Privacy Shield for legal reasons. Therefore, explicit consent for use of the ASA24® tool will be sought from participants. For further information on the tool: https://epi.grants.cancer.gov/asa24/.
EDUQ Validation
The validation procedure will occur over eight weeks consisting of administering eight 24-hour diary of ED use (24-hour ED use diary) and the EDUQ at three time points. The time points for the eight 24-hour ED use diaries will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on weekdays. The EDUQ will be completed at baseline and at the conclusion of weeks four and eight. Upon consenting to participate on the Checkbox® by proceeding to the questionnaires, participants will be instructed to fill out:
- The EDUQ: A 22-item questionnaire that takes 20 minutes to complete, and measures participant demographic information (weight, height, age, highest level of education, occupational status, post-code and country of residence), usual daily ED use from present up to 20 years ago, occupational influence to use, and differences to ED use between a weekend and weekday (questionnaire adapted from Williams et al. (2019) (21). Personal information collected as part of this questionnaire is to qualify the characteristics of the population in which the tool is being validated. Data collected via Checkbox®.
- 24-hour ED use diary: Participants will be asked to record their ED use in hours and minutes over 24 hours. Data collected via Checkbox®.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food Frequency Questionnaire Validation Group | – | Other: Weekly Food Frequency Questionnaire, Other: Monthly Food Frequency Questionnaire, Other: 24-Hour Diet RecallThe validation procedure will span over four weeks, consisting of administering the Lutein and Zeaxanthin Food Frequency Questionnaire (FFQ L/Z) and 24-hour diet recalls at multiple timepoints. Timepoints for the eight 24-hour diet recalls will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on week days. * The weekly L/Z FFQ will be completed at the conclusion of each of the four weeks. * The monthly L/Z FFQ will be completed at baseline and at the conclusion of week four. |
| Electronic Device Use Questionnaire Validation Group | – | Other: Electronic Device Use Questionnaire, Other: 24-Hour Electronic Device Use DiaryThe validation procedure will occur over eight weeks consisting of administering eight 24-hour diary of electronic device use (24-hour ED use diary) and the Electronic Device Use Questionnaire (EDUQ) at three time points. The time points for the eight 24-hour ED use diaries will be determined by random number generator for each of the participants at baseline (https://www.random.org/), of which two will take place on weekend days, and the remainder on weekdays. The EDUQ will be completed at baseline and at the conclusion of weeks four and eight. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Generally healthy male and female adults from Australia or the United Kingdom.
Key inclusion criteria (2 listed)
- Healthy males and females 18 years and over.
- Access to an ED such as a computer, phone, or tablet, and internet to complete investigations.
Key exclusion criteria (2 listed)
- Visual, hearing, or physical impairment that may prevent from completing investigations.
- No English literacy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly Food Frequency QuestionnaireA purpose designed 91-item questionnaire to measure frequency of consumption of a selection of L/Z containing foods over the prior 7 days. | Other | Food Frequency Questionnaire Validation Group |
| Monthly Food Frequency QuestionnaireA purpose designed 95-item questionnaire completed at visit 1 to measure frequency of consumption of a selection of L/Z containing foods over the prior month. | Other | Food Frequency Questionnaire Validation Group |
| 24-Hour Diet Recallthe diet recall via the online Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24®) takes approximately 25 minutes to complete, and investigates food and beverages consumed in the prior 24-hours. | Other | Food Frequency Questionnaire Validation Group |
| Electronic Device Use Questionnaire1. The EDUQ: A 22-item questionnaire that takes 20 minutes to complete, and measures participant demographic information (weight, height, age, highest level of education, occupational status, post-code and country of residence), usual daily ED use from present up to 20 years ago, occupational influence to use, and differences to ED use between a weekend and weekday. | Other | Electronic Device Use Questionnaire Validation Group |
| 24-Hour Electronic Device Use DiaryParticipants asked to record their electronic device use in hours and minutes over 24 hours. | Other | Electronic Device Use Questionnaire Validation Group |
Primary outcome
Daily Intake of lutein and zeaxanthin
Time frame: 4 weeks
Calculation from each dietary intake tool what the daily milligrams of lutein and zeaxanthin intake is.
Daily hours of electronic device use.
Time frame: 8 weeks
Calculation from the two device use recording tools what the daily hours of electronic device use is for each participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Background: PubMed 29049463Keel S, Xie J, Foreman J, van Wijngaarden P, Taylor HR, Dirani M. Prevalence of Age-Related Macular Degeneration in Australia: The Australian National Eye Health Survey. JAMA Ophthalmol. 2017 Nov 1;135(11):1242-1249. doi: 10.1001/jamaophthalmol.2017.4182.
- Background: PubMed 26541886Bernstein PS, Li B, Vachali PP, Gorusupudi A, Shyam R, Henriksen BS, Nolan JM. Lutein, zeaxanthin, and meso-zeaxanthin: The basic and clinical science underlying carotenoid-based nutritional interventions against ocular disease. Prog Retin Eye Res. 2016 Jan;50:34-66. doi: 10.1016/j.preteyeres.2015.10.003. Epub 2015 Nov 2.
- Background: PubMed 24368940Velilla S, Garcia-Medina JJ, Garcia-Layana A, Dolz-Marco R, Pons-Vazquez S, Pinazo-Duran MD, Gomez-Ulla F, Arevalo JF, Diaz-Llopis M, Gallego-Pinazo R. Smoking and age-related macular degeneration: review and update. J Ophthalmol. 2013;2013:895147. doi: 10.1155/2013/895147. Epub 2013 Dec 4.
- Background: PubMed 24792100Chiu CJ, Chang ML, Zhang FF, Li T, Gensler G, Schleicher M, Taylor A. The relationship of major American dietary patterns to age-related macular degeneration. Am J Ophthalmol. 2014 Jul;158(1):118-127.e1. doi: 10.1016/j.ajo.2014.04.016. Epub 2014 Apr 29.
- Background: PubMed 16950247Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. doi: 10.1016/j.survophthal.2006.06.009.
- Background: PubMed 16445433Algvere PV, Marshall J, Seregard S. Age-related maculopathy and the impact of blue light hazard. Acta Ophthalmol Scand. 2006 Feb;84(1):4-15. doi: 10.1111/j.1600-0420.2005.00627.x.
- Background: PubMed 21600300Behar-Cohen F, Martinsons C, Vienot F, Zissis G, Barlier-Salsi A, Cesarini JP, Enouf O, Garcia M, Picaud S, Attia D. Light-emitting diodes (LED) for domestic lighting: any risks for the eye? Prog Retin Eye Res. 2011 Jul;30(4):239-57. doi: 10.1016/j.preteyeres.2011.04.002. Epub 2011 May 14.
- Background: PubMed 24883226Widomska J, Subczynski WK. Why has Nature Chosen Lutein and Zeaxanthin to Protect the Retina? J Clin Exp Ophthalmol. 2014 Feb 21;5(1):326. doi: 10.4172/2155-9570.1000326.
- Background: PubMed 27878403Liu T, Liu WH, Zhao JS, Meng FZ, Wang H. Lutein protects against beta-amyloid peptide-induced oxidative stress in cerebrovascular endothelial cells through modulation of Nrf-2 and NF-kappab. Cell Biol Toxicol. 2017 Feb;33(1):57-67. doi: 10.1007/s10565-016-9360-y. Epub 2016 Nov 22.
- Background: PubMed 28665123Frede K, Ebert F, Kipp AP, Schwerdtle T, Baldermann S. Lutein Activates the Transcription Factor Nrf2 in Human Retinal Pigment Epithelial Cells. J Agric Food Chem. 2017 Jul 26;65(29):5944-5952. doi: 10.1021/acs.jafc.7b01929. Epub 2017 Jul 13.
- Background: PubMed 19248870Satia JA, Watters JL, Galanko JA. Validation of an antioxidant nutrient questionnaire in whites and African Americans. J Am Diet Assoc. 2009 Mar;109(3):502-8, 508.e1-6. doi: 10.1016/j.jada.2008.11.033.
- Background: PubMed 10427874Romieu I, Parra S, Hernandez JF, Madrigal H, Willett W, Hernandez M. Questionnaire assessment of antioxidants and retinol intakes in Mexican women. Arch Med Res. 1999 May-Jun;30(3):224-39. doi: 10.1016/s0188-0128(99)00017-2.
- USDA Food Composition DatabaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lutein and Zeaxanthin Dietary Intake and Age Related Macular Degeneration, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Intake of lutein and zeaxanthin (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04779411, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.