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Food or Supplemental Lutein Absorption

Phase 1
Withdrawn
Conditions
Macula Lutea Opacity
Interventions
Other: Food, blended
Other: Food, unprocessed
Dietary Supplement: Lutein supplement
Registration Number
NCT04786392
Lead Sponsor
The University of Queensland
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.

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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).

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Blended food beverageFood, blendedBlended food beverage containing 5 mg lutein from baby spinach. To be administered/consumed once.
Whole foodFood, unprocessedConsumption of 5 mg of lutein from baby spinach. To be administered/consumed once.
Lutein supplementLutein supplementSupplement containing 5 mg powdered lutein, capsule filler microcrystalline cellulose. To be administered once.
Primary Outcome Measures
NameTimeMethod
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 Outcome Measures
NameTimeMethod
Macular pigment optical densityStudy visit day 1, day 8, day 15

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).

Daily dietary lutein and zeaxanthin intakeStudy visit day 1, day 8, day 15

Daily dietary intake of lutein and zeaxanthin (mg/day) as measured by a food frequency questionnaire.

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.

Trial Locations

Locations (1)

School of Human Movement and Nutrition Sciences, The University of Queensland

🇦🇺

Saint Lucia, Queensland, Australia

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