Macula Lutea OpacityPhase 1FSLA20NCT04786392
Food or Supplemental Lutein Absorption
A Phase 1 study testing Lutein supplement, Food, blended and Food, unprocessed in people with Macula Lutea Opacity, run by The University of Queensland at 1 site in Australia.
Trial summary
The aim of this study is to investigate in healthy adults, 18-40 years of age, how the absorption of 5 mg of L differs between consumption as a supplement, blended foods, and whole food equivalent of blended foods. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Macula Lutea Opacity
- What is being tested?
- Lutein supplement, Food, blended and Food, unprocessed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 2021to Jun 2021
- Phase
- Phase 1
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and females 18 to 40 years.
- Generally healthy.
- No participant reported history of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
- Non-smoker.
- English language proficiency
Who cannot join
- Participant reported diagnosis of serious ocular conditions (e.g. cataracts, glaucoma, diabetic retinopathy, retinitis pigmentosa, Stagardt's disease)
- Participant reported diagnosis, or current treatment of age-related macular degeneration.
- Participant reported diagnosis of epilepsy.
- Participant aversion, intolerance or allergy to study foods to be consumed (spinach, ginger, lemon, apple, flaxseeds)
- A female currently pregnant or trying to fall pregnant.
- Current or past smoker (within last 12 months).
- Under 18 or over 40 years of age.
- Currently taking a lutein supplement or consuming large amounts of foods containing lutein on a regular basis (>3 days per week).
Trial locations and contacts
1 site in 1 country.
Australia1 site
School of Human Movement and Nutrition Sciences, The University of Queensland
Saint Lucia, Queensland, 4067
About this study
Official title: Lutein Absorption Consumed as Supplement, Blended Food, or Wholefood Over 24-hours.
The aim of this study is to investigate in healthy adults, 18-40 years of age, how the absorption of 5 mg of L differs between consumption as a supplement, blended foods, and whole food equivalent of blended foods.
Read the detailed description
The absorption the macular carotenoids has shown variability between different supplements, and food sources such as egg and spinach. Investigation of the absorption of different forms of food (e.g. cooked, raw, blended) is not as well studied. Investigating the absorption of lutein from different forms of food is important to be able to prescribe lutein from forms of food that will be optimally absorbed.
- Conditions
- Macula Lutea Opacity
- Being tested
- Lutein supplement, Food, blended, Food, unprocessed
- Keywords
- lutein, absorption, supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lutein supplementDietary supplement
5 mg lutein supplement.
Food, blendedOther
5 mg lutein from baby spinach, blended.
Food, unprocessedOther
5 mg lutein from baby spinach, in whole food form.
| Study group | Role | What they receive |
|---|---|---|
| Lutein supplement | Active comparator | Supplement containing 5 mg powdered lutein, capsule filler microcrystalline cellulose.
To be administered once. Receives: Dietary Supplement: Lutein supplement |
| Blended food beverage | Experimental | Blended food beverage containing 5 mg lutein from baby spinach. To be administered/consumed once. Receives: Other: Food, blended |
| Whole food | Experimental | Consumption of 5 mg of lutein from baby spinach. To be administered/consumed once. Receives: Other: Food, unprocessed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lutein concentration
Area under the curve of plasma lutein concentrations between 0 and 24 hours post lutein consumption.
Measured: Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)
Secondary outcomes (4)
Plasma lutein maximum concentration
Maximum concentration of plasma lutein reached over 24 hours of measurement, and time point of maximum concentration.
Measured: Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)
Macular pigment optical density
Machine: measured by the Macular Pigment Screener II (Elektron Eye Technology). The non-invasive test uses heterochromatic flicker photometry. One measure completed at each study visit (3 study visits total).
Measured: Study visit day 1, day 8, day 15
Daily dietary lutein and zeaxanthin intake
Daily dietary intake of lutein and zeaxanthin (mg/day) as measured by a food frequency questionnaire.
Measured: Study visit day 1
Daily dietary lutein and zeaxanthin intake
Daily dietary intake of lutein and zeaxanthin (mg/day) as measured by a food frequency questionnaire.
Measured: Study visit day 1, day 8, day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJun 2021 (estimated)
Why it stopped: Unable to fit within PhD timeline.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Macula Lutea OpacityStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veronique Chahay, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786392
- Sponsor's protocol ID
- 2020002809
- Acronym
- FSLA20
- Status last verified
- Jan 2021
- First submitted
- 26 Feb 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernstein 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 26541886Chiu 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 16950247Widomska 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 28665123Howells O, Eperjesi F, Bartlett H. Measuring macular pigment optical density in vivo: a review of techniques. Graefes Arch Clin Exp Ophthalmol. 2011 Mar;249(3):315-47. doi: 10.1007/s00417-010-1577-5. Epub 2011 Jan 8.
PubMed 21221629Kopsell DA, Lefsrud MG, Kopsell DE, Wenzel AJ, Gerweck C, Curran-Celentano J. Spinach cultigen variation for tissue carotenoid concentrations influences human serum carotenoid levels and macular pigment optical density following a 12-week dietary intervention. J Agric Food Chem. 2006 Oct 18;54(21):7998-8005. doi: 10.1021/jf0614802.
PubMed 17032001van der Made SM, Kelly ER, Kijlstra A, Plat J, Berendschot TT. Increased Macular Pigment Optical Density and Visual Acuity following Consumption of a Buttermilk Drink Containing Lutein-Enriched Egg Yolks: A Randomized, Double-Blind, Placebo-Controlled Trial. J Ophthalmol. 2016;2016:9035745. doi: 10.1155/2016/9035745. Epub 2016 Mar 14.
PubMed 27064326Taibi G, Nicotra CM. Development and validation of a fast and sensitive chromatographic assay for all-trans-retinol and tocopherols in human serum and plasma using liquid-liquid extraction. J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Nov 25;780(2):261-7. doi: 10.1016/s1570-0232(02)00529-9.
PubMed 12401351Chung HY, Rasmussen HM, Johnson EJ. Lutein bioavailability is higher from lutein-enriched eggs than from supplements and spinach in men. J Nutr. 2004 Aug;134(8):1887-93. doi: 10.1093/jn/134.8.1887.
PubMed 15284371Aebischer CP, Schierle J, Schuep W. Simultaneous determination of retinol, tocopherols, carotene, lycopene, and xanthophylls in plasma by means of reversed-phase high-performance liquid chromatography. Methods Enzymol. 1999;299:348-62. doi: 10.1016/s0076-6879(99)99035-3. No abstract available.
PubMed 9916214
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lutein Absorption Consumed as Supplement, Blended Food, or Wholefood Over 24-hours.
- ClinicalTrials.gov ID
- NCT04786392
- Acronym / sponsor ID
- FSLA20 / 2020002809
- Conditions
- Macula Lutea Opacity
- Keywords
- lutein, absorption, supplement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to fit within PhD timeline.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 8 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.
The aim of this study is to investigate in healthy adults, 18-40 years of age, how the absorption of 5 mg of L differs between consumption as a supplement, blended foods, and whole food equivalent of blended foods.
Detailed description
The absorption the macular carotenoids has shown variability between different supplements, and food sources such as egg and spinach. Investigation of the absorption of different forms of food (e.g. cooked, raw, blended) is not as well studied. Investigating the absorption of lutein from different forms of food is important to be able to prescribe lutein from forms of food that will be optimally absorbed.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lutein supplement | Active comparator | Dietary Supplement: Lutein supplementSupplement containing 5 mg powdered lutein, capsule filler microcrystalline cellulose. To be administered once. |
| Blended food beverage | Experimental | Other: Food, blendedBlended food beverage containing 5 mg lutein from baby spinach. To be administered/consumed once. |
| Whole food | Experimental | Other: Food, unprocessedConsumption of 5 mg of lutein from baby spinach. To be administered/consumed once. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and females 18 to 40 years.
- Generally healthy.
- No participant reported history of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
- Non-smoker.
- English language proficiency
Key exclusion criteria (8 listed)
- Participant reported diagnosis of serious ocular conditions (e.g. cataracts, glaucoma, diabetic retinopathy, retinitis pigmentosa, Stagardt's disease)
- Participant reported diagnosis, or current treatment of age-related macular degeneration.
- Participant reported diagnosis of epilepsy.
- Participant aversion, intolerance or allergy to study foods to be consumed (spinach, ginger, lemon, apple, flaxseeds)
- A female currently pregnant or trying to fall pregnant.
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 |
|---|---|---|
| Lutein supplement5 mg lutein supplement. | Dietary supplement | Lutein supplement |
| Food, blended5 mg lutein from baby spinach, blended. | Other | Blended food beverage |
| Food, unprocessed5 mg lutein from baby spinach, in whole food form. | Other | Whole food |
Primary outcome
Plasma lutein concentration
Time frame: Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)
Area under the curve of plasma lutein concentrations between 0 and 24 hours post lutein consumption.
4 secondary outcomes
Plasma lutein maximum concentration
Time frame: Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)
Macular pigment optical density
Time frame: Study visit day 1, day 8, day 15
Daily dietary lutein and zeaxanthin intake
Time frame: Study visit day 1
Daily dietary lutein and zeaxanthin intake
Time frame: Study visit day 1, day 8, day 15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- 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 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 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 21221629Howells O, Eperjesi F, Bartlett H. Measuring macular pigment optical density in vivo: a review of techniques. Graefes Arch Clin Exp Ophthalmol. 2011 Mar;249(3):315-47. doi: 10.1007/s00417-010-1577-5. Epub 2011 Jan 8.
- Background: PubMed 17032001Kopsell DA, Lefsrud MG, Kopsell DE, Wenzel AJ, Gerweck C, Curran-Celentano J. Spinach cultigen variation for tissue carotenoid concentrations influences human serum carotenoid levels and macular pigment optical density following a 12-week dietary intervention. J Agric Food Chem. 2006 Oct 18;54(21):7998-8005. doi: 10.1021/jf0614802.
- Background: PubMed 27064326van der Made SM, Kelly ER, Kijlstra A, Plat J, Berendschot TT. Increased Macular Pigment Optical Density and Visual Acuity following Consumption of a Buttermilk Drink Containing Lutein-Enriched Egg Yolks: A Randomized, Double-Blind, Placebo-Controlled Trial. J Ophthalmol. 2016;2016:9035745. doi: 10.1155/2016/9035745. Epub 2016 Mar 14.
- Background: PubMed 12401351Taibi G, Nicotra CM. Development and validation of a fast and sensitive chromatographic assay for all-trans-retinol and tocopherols in human serum and plasma using liquid-liquid extraction. J Chromatogr B Analyt Technol Biomed Life Sci. 2002 Nov 25;780(2):261-7. doi: 10.1016/s1570-0232(02)00529-9.
- Background: PubMed 15284371Chung HY, Rasmussen HM, Johnson EJ. Lutein bioavailability is higher from lutein-enriched eggs than from supplements and spinach in men. J Nutr. 2004 Aug;134(8):1887-93. doi: 10.1093/jn/134.8.1887.
- Background: PubMed 9916214Aebischer CP, Schierle J, Schuep W. Simultaneous determination of retinol, tocopherols, carotene, lycopene, and xanthophylls in plasma by means of reversed-phase high-performance liquid chromatography. Methods Enzymol. 1999;299:348-62. doi: 10.1016/s0076-6879(99)99035-3. No abstract available.
- 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.
Veronique Chahay, PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lutein supplement, Food, blended and Food, unprocessed in people with Macula Lutea Opacity, 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 12 Jul 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Plasma lutein concentration (time frame: Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)). 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 NCT04786392, which also lists 12 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 12 Jul 2021.