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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04786392




Registration number
NCT04786392
Ethics application status
Date submitted
26/02/2021
Date registered
8/03/2021
Date last updated
12/07/2021

Titles & IDs
Public title
Food or Supplemental Lutein Absorption
Scientific title
Lutein Absorption Consumed as Supplement, Blended Food, or Wholefood Over 24-hours.
Secondary ID [1] 0 0
2020002809
Universal Trial Number (UTN)
Trial acronym
FSLA20
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macula Lutea Opacity 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Lutein supplement
Other interventions - Food, blended
Other interventions - Food, unprocessed

Active Comparator: Lutein supplement - Supplement containing 5 mg powdered lutein, capsule filler microcrystalline cellulose.
To be administered once.

Experimental: Blended food beverage - Blended food beverage containing 5 mg lutein from baby spinach. To be administered/consumed once.

Experimental: Whole food - Consumption of 5 mg of lutein from baby spinach. To be administered/consumed once.


Other interventions: Lutein supplement
5 mg lutein supplement.

Other interventions: Food, blended
5 mg lutein from baby spinach, blended.

Other interventions: Food, unprocessed
5 mg lutein from baby spinach, in whole food form.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma lutein concentration
Timepoint [1] 0 0
Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)
Secondary outcome [1] 0 0
Plasma lutein maximum concentration
Timepoint [1] 0 0
Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)
Secondary outcome [2] 0 0
Macular pigment optical density
Timepoint [2] 0 0
Study visit day 1, day 8, day 15
Secondary outcome [3] 0 0
Daily dietary lutein and zeaxanthin intake
Timepoint [3] 0 0
Study visit day 1
Secondary outcome [4] 0 0
Daily dietary lutein and zeaxanthin intake
Timepoint [4] 0 0
Study visit day 1, day 8, day 15

Eligibility
Key inclusion criteria
- 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
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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).

Study design
Purpose of the study
Basic Science
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2021
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
School of Human Movement and Nutrition Sciences, The University of Queensland - Saint Lucia
Recruitment postcode(s) [1] 0 0
4067 - Saint Lucia

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04786392
Trial related presentations / 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.
Chiu 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.
Wu 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.
Widomska 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.
Liu 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.
Frede 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.
Howells 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.
Kopsell 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.
van 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.
Taibi 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.
Chung 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.
Aebischer 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.
Public notes

Contacts
Principal investigator
Name 0 0
Veronique Chahay, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04786392