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Food or Supplemental Lutein Absorption

Lutein Absorption Consumed as Supplement, Blended Food, or Wholefood Over 24-hours.

Status
Withdrawn
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04786392
Acronym
FSLA20
Enrollment
0
Registered
2021-03-08
Start date
2021-06-30
Completion date
2021-06-30
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macula Lutea Opacity

Keywords

lutein, absorption, supplement

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.

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.

Interventions

DIETARY_SUPPLEMENTLutein supplement

5 mg lutein supplement.

OTHERFood, blended

5 mg lutein from baby spinach, blended.

OTHERFood, unprocessed

5 mg lutein from baby spinach, in whole food form.

Sponsors

The University of Queensland
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

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).

Design outcomes

Primary

MeasureTime frameDescription
Plasma lutein concentrationStudy 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.

Secondary

MeasureTime frameDescription
Plasma lutein maximum concentrationStudy visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)Maximum concentration of plasma lutein reached over 24 hours of measurement, and time point of maximum concentration.
Macular pigment optical densityStudy visit day 1, day 8, day 15Machine: 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).
Daily dietary lutein and zeaxanthin intakeStudy visit day 1Daily dietary intake of lutein and zeaxanthin (mg/day) as measured by a food frequency questionnaire.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026