Lutein Supplementation in Healthy Children

N

Northcentral University

Status

Active, not recruiting

Conditions

Cognitive Change
Eye Fatigue
Diet, Healthy

Treatments

Dietary Supplement: lutein
Dietary Supplement: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05314647
NorthcentralU

Details and patient eligibility

About

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.

Full description

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.

Enrollment

59 patients

Sex

All

Ages

8 to 16 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

59 participants in 2 patient groups, including a placebo group

Lutein
Experimental group
Description:
5 mg lutein gummy taken daily for 180 days
Treatment:
Dietary Supplement: lutein
Placebo
Placebo Comparator group
Description:
0 mg lutein gummy taken daily for 180 days
Treatment:
Dietary Supplement: placebo

Trial contacts and locations

1

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Central trial contact

Brenda Fonseca, MA

Data sourced from clinicaltrials.gov

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