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Lutein Supplementation in Healthy Children

NCT ID: NCT05314647

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2024-05-31

Brief Summary

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This is a single site, randomized, double-blind placebo controlled parallel arm study assessing the effects of 6 months lutein supplementation on cognitive and visual outcomes in healthy children exposed to excessive digital screen time.

Detailed Description

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Studies in humans and primates have also shown that appropriate daily intake of lutein provides protection to the eyes from blue light from screen time devices such as computers, televisions and phones. It has been well-documented that children are spending far over the recommended two hours screen time per day and excessive exposure to the high energy blue light associated with digital devices has been shown to cause both short-term and long-term visual damage as well as disruption to the sleep cycle. With a globally aging population, if this deficit is not addressed adequately early on in life then there will be substantial public health consequences. A recent study predicted that if individuals were to consume the recommended levels of lutein and zeaxanthin daily, there would be a seven percent reduced risk for age related eye disease and a potential savings of over five billion US dollars annually.

Conditions

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Eye Fatigue Diet, Healthy Cognitive Change

Keywords

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lutein carotenoids blue light screen time digital stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized, double-blind, placebo controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Each participant will be assigned to a group based on a permuted block randomization stratified by participant self-reported sex. Participants may identify male, female or other. If other is selected, assignment as male or female for randomization purposes will be determined by a coin flip. Randomized block lists with a size of 4 will be prepared using a computer generated random number sequence, http://www.jerrydallal.com/random/assigndoc.htm#num (J. Kim \& Shin, 2014). Based on group placement, participants will be provided with Bottle A or Bottle B of gummies to last for the next 90 days.

Study Groups

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Lutein

5 mg lutein gummy taken daily for 180 days

Group Type EXPERIMENTAL

lutein

Intervention Type DIETARY_SUPPLEMENT

daily dose of 5 mg lutein

Placebo

0 mg lutein gummy taken daily for 180 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

daily dose of 0 mg lutein

Interventions

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lutein

daily dose of 5 mg lutein

Intervention Type DIETARY_SUPPLEMENT

placebo

daily dose of 0 mg lutein

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FloraGLO Lutein

Eligibility Criteria

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Inclusion Criteria

* Age of 8 to 16 years
* guardian-reported general good health
* guardian-reported 4 hours or more of digital screen time daily

Exclusion Criteria

* Currently using a supplement containing lutein or zeaxanthin
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northcentral University

OTHER

Sponsor Role lead

Responsible Party

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Brenda Fonseca

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick McNamara, PhD

Role: STUDY_CHAIR

Northcentral University

Locations

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Kemin Industries

Des Moines, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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NorthcentralU

Identifier Type: -

Identifier Source: org_study_id