Food or Supplemental Lutein Absorption

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Macula Lutea Opacity

Intervention / Treatment
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* Dietary Supplement: Lutein supplement
* Other: Food, blended
* Other: Food, unprocessed


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lutein supplement<br>Supplement containing 5 mg powdered lutein, capsule filler microcrystalline cellulose. To be administered once. | Dietary Supplement: Lutein supplement<br>* 5 mg lutein supplement.<br>|
| Experimental: Blended food beverage<br>Blended food beverage containing 5 mg lutein from baby spinach. To be administered/consumed once. | Other: Food, blended<br>* 5 mg lutein from baby spinach, blended.<br>|
| Experimental: Whole food<br>Consumption of 5 mg of lutein from baby spinach. To be administered/consumed once. | Other: Food, unprocessed<br>* 5 mg lutein from baby spinach, in whole food form.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lutein concentration | Area under the curve of plasma lutein concentrations between 0 and 24 hours post lutein consumption. | Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lutein maximum concentration | Maximum concentration of plasma lutein reached over 24 hours of measurement, and time point of maximum concentration. | 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). | 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. | 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. | Study visit day 1, day 8, day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lutein, absorption, supplement