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

NCT03983525 | Completed DMC

• 1 other identifier: 1220178
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Macular pigment ocular density (MPOD)

  MPOD measurement - MPOD will be assessed by the psychophysical method of HFP technology (Macular Metrics, Providence, RI). Participants will watch a 20 minutes long video of a description of HFP. After adapting to the dark for seven minutes, participants will be asked to rest their head on a chin rest and look at a blue background field for three minutes. Prior to each test, the light intensity from each wavelength will be calibrated with a photodiode. The flicker frequency is selected for each subject based on preliminary tests of flicker sensitivity. The observer's task is to eliminate or minimize the flicker by turning a dial that changes the intensity of the 460-nm light. They will be asked to do this when looking directly at the flickering light and also when looking at a fixation point so that the stimulus can be presented in the periphery.

  90 days

Secondary Outcomes (2)

• Skin carotenoids concentration

  90 days

• Gut fermentation measured as the hydrogen content in the breath

  90 days

Study Arms (2)

Goji berry

EXPERIMENTAL

The study will include three study visits over a 90 days period, with study visit one (SV1) occurring at day 0 SV2 conducted at day 45, and SV3 conducted at day 90. The participant will be provided with either a 45-day supply of goji berries and will be asked to consume the given items five days per week. After the 45-day intake period, the participants will return to the lab for SV2 and then be given a new 45-day supply of items to consume until the end of the 90 day test period (SV3).

Dietary Supplement: Goji berry

Lutein + zeaxanthin supplementation

ACTIVE COMPARATOR

The study will include three study visits over a 90 days period, with study visit one (SV1) occurring at day 0. SV2 conducted at day 45, and SV3 conducted at day 90. The participant will be provided with L/Z supplements which contains 6 mg of lutein and 4 mg of zeaxanthin and will be asked to consume the given items five days per week. After the 45-day intake period, the participants will return to the lab for SV2 and then be given a new 45-day supply of items to consume until the end of the 90 day test period (SV3).

Dietary Supplement: Lutein + zeaxanthin supplementation

Interventions

Goji berry DIETARY_SUPPLEMENT

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.

Goji berry

Lutein + zeaxanthin supplementation DIETARY_SUPPLEMENT

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.

Lutein + zeaxanthin supplementation

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female:45-65 years Willing and able to comply with the study protocols Normal macular condition verified by optometry office Stable on prescription medication use, for at least the past 6 months, as approved by the study physician

You may not qualify if:

• Dislike of or allergy to goji berry Self-reported diabetes, renal or liver disease, heart disease, which includes cardiovascular events and stroke, cancer, malabsorption problems, substance abuse or eye diseases
• Smoking:
• Current smokers
• Those that have smoked within the past year
• Former smokers with greater than a 20 pack-year history of smoking within the past 20 years Indications of substance or alcohol abuse Current or planned use of blood thinner (eg. Coumadin, Warfarin) at any time during study
• Currently taking zeaxanthin or lutein supplements Use of multi-vitamin and mineral supplements other than a general formula that provides up to 100% of the Daily Value Not willing to stop dietary supplement use at least one month prior to study enrollment Currently taking drugs for management of lipids, glucose or blood pressure statin drugs A current enrollee in a clinical research study

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

Regal Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Interventions

Lutein

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized paralleled arm clinical trial

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 12, 2019
• Study Start: June 10, 2019
• Primary Completion: May 28, 2020
• Study Completion: June 15, 2020
• Last Updated: July 23, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)