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The Effect of Gojiberry Intake (Lycium Barbarium) on Macular Function

NCT03983525 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-07-23

No results posted yet for this study

Summary

Objective: To evaluate the effects of goji berry intake for three months on macular pigment ocular density (MPOD) between 45 and 65 years old.

Specific Aims:

Determine if goji berry intake for 90 days, 5 times per week, will:

* result in favorable changes in macular pigment optical density (MPOD), as measured using heterochromatic flicker photometry (HFP), in adults aged from 45 to 65 years old.
* impact the carotenoid distribution in the skin.
* will change the fermentation capacity of the gut microbiota.

The investigators hypothesize that the intake of 28 grams of goji berry for 90 days, 5 days per week will significantly increase MPOD after three months, compared to baseline values. In contrast, the investigators hypothesize that a dietary supplement of lutein and zeaxanthin will not alter MPOD.

Conditions

  • Macular Pigment Optical Density

Interventions

DIETARY_SUPPLEMENT

Goji berry

Those who are eligible for enrollment will be required to participate in three study visits over a three-month period, with each visit lasting approximately one and half hour. The three study visits will be separated by 45 +/- 2 days. During each study period, the participants are required to take 28 grams of goji berry once a day, five times per week, and will complete a set of 24 hour dietary recall, using an online automated self-administered recall system known as the ASA24.

DIETARY_SUPPLEMENT

Lutein + zeaxanthin supplementation

Those who are eligible for enrollment will be required to participate in three study visits over a three-month period, with each visit lasting approximately one and half hour. The three study visits will be separated by 45 +/- 2 days. During each study period, the participants are required to take one capsule of lutein + zeaxanthin supplementation once a day, five times per week, and will complete a set of 24 hour dietary recall, using an online automated self-administered recall system known as the ASA24.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2020-05-28
Completion
2020-06-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03983525 on ClinicalTrials.gov