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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Queensland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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