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FSLA20: Food or Supplemental Lutein Absorption

Sponsor
The University of Queensland (Other)
Overall Status
Withdrawn
CT.gov ID
NCT04786392
Collaborator
(none)
0
Enrollment
1
Location
3
Arms

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Lutein supplement
  • Other: Food, blended
  • Other: Food, unprocessed
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Lutein Absorption Consumed as Supplement, Blended Food, or Wholefood Over 24-hours.
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lutein supplement

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

Dietary Supplement: Lutein supplement
5 mg lutein supplement.
Experimental: Blended food beverage

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

Other: Food, blended
5 mg lutein from baby spinach, blended.
Experimental: Whole food

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

Other: Food, unprocessed
5 mg lutein from baby spinach, in whole food form.

Outcome Measures

Primary Outcome Measures

  1. Plasma lutein concentration [Study 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

  1. Plasma lutein maximum concentration [Study 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.

  2. Macular pigment optical density [Study 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).

  3. Daily dietary lutein and zeaxanthin intake [Study visit day 1]

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

  4. Daily dietary lutein and zeaxanthin intake [Study visit day 1, day 8, day 15]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Human Movement and Nutrition Sciences, The University of Queensland Saint Lucia Queensland Australia 4067

Sponsors and Collaborators

  • The University of Queensland

Investigators

  • Principal Investigator: Veronique Chahay, PhD, The University of Queensland

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
The University of Queensland
ClinicalTrials.gov Identifier:
NCT04786392
Other Study ID Numbers:
  • 2020002809
First Posted:
Mar 8, 2021
Last Update Posted:
Jul 12, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by The University of Queensland
lutein
absorption
supplement

Study Results

No Results Posted as of Jul 12, 2021