Food or Supplemental Lutein Absorption (FSLA20)

The University of Queensland

Status and phase: Withdrawn; Phase 1

Conditions: Macula Lutea Opacity

Treatments: Other: Food, unprocessed; Dietary Supplement: Lutein supplement; Other: Food, blended

Study type: Interventional

Funder types: Other

Identifiers

NCT04786392

2020002809

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Lutein supplement

Active Comparator group

Description:

Supplement containing 5 mg powdered lutein, capsule filler microcrystalline cellulose. To be administered once.

Treatment:

Dietary Supplement: Lutein supplement

Blended food beverage

Experimental group

Description:

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

Treatment:

Other: Food, blended

Whole food

Experimental group

Description:

Consumption of 5 mg of lutein from baby spinach. To be administered/consumed once.

Treatment:

Other: Food, unprocessed