Food or Supplemental Lutein Absorption (FSLA20)

July 6, 2021 updated by: The University of Queensland

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Saint Lucia, Queensland, Australia, 4067
        • School of Human Movement and Nutrition Sciences, The University of Queensland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma lutein concentration
Time Frame: 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.
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
Time Frame: 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.
Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours)
Macular pigment optical density
Time Frame: 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).
Study visit day 1, day 8, day 15
Daily dietary lutein and zeaxanthin intake
Time Frame: Study visit day 1
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
Time Frame: Study visit day 1, day 8, day 15
Daily dietary intake of lutein and zeaxanthin (mg/day) as measured by a food frequency questionnaire.
Study visit day 1, day 8, day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Actual)

July 12, 2021

Last Update Submitted That Met QC Criteria

July 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2020002809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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