Macular Pigment Optical DensityNCT03983525
The Effect of Gojiberry Intake (Lycium Barbarium) on Macular Function
A study testing Goji berry and Lutein + zeaxanthin supplementation in people with Macular Pigment Optical Density, run by University of California, Davis at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Macular Pigment Optical Density
- What is being tested?
- Goji berry and Lutein + zeaxanthin supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2019to 15 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Regal Human Nutrition Research Center
Davis, California, 95616
About this study
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:
Read more
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.
Read the detailed description
Prior to enrollment, all volunteers that meet the initial inclusion and exclusion based on a telephone interview will be asked to participate in a clinical screening visit, which will assess the subject's overall health, and whether the individual meets the inclusion and exclusion criteria. To determine normal eye health, subjects will provide a statement from their optometrist verifying normal functioning. The study will be conducted in the Ragle Human Nutrition Research Center on the UC Davis campus. The participants will be consented into the study. For those who are not familiar with goji berry, a sample tasting will be provided. In addition, each volunteer will be asked to complete a diet and health habits questionnaire. The first study visit will begin on the same day after the screening visit is done.
The study will be a randomized, controlled, parallel arm design with two groups: goji berry or lutein/zeaxanthin (L/Z) supplement. Participants will be randomly assigned to one of the two groups using a block design that will place an approximately similar number of males and females in each group. The randomization will be conducted by an online tool called Research Randomizer.
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 first study visit will occur immediately after consent is completed.
Depending on group assignment, the participant will be provided with either a 45-day supply of goji berries or 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). Participants will complete a log in order to verify compliance. Dietary recall will be collected by using the Automated Self-Administered 24-hour dietary assessment (ASA24) web-based tool between each SV.
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.
Skin carotenoid measurement - the carotenoid content in the skin will be measured through a finger-scanning device using reflection spectroscopy (this process does not capture fingerprints) called the Veggie Meter (VM). This noninvasive method of measuring skin carotenoid levels has been validated to reflect plasma carotenoid concentrations.
Breath Hydrogen measurement - the participant will be asked to do one short exhalation (about 2-3 seconds) into a collection tube. Their breath sample will be analyzed for hydrogen and methane that are produced by fermentation of carbohydrates (including fiber) in the digestive tract.
Compliance will be assessed verbally and through self-reported logs indicating consumption of the product. Dietary recall will be collected by using the Automated Self-Administered 24-hour dietary assessment (ASA24) web-based tool during each study arm, and a weekly log book of digestive tract symptoms, which will record a typical symptom such as bloating, gas, intestinal cramps, and loose stools.
- Conditions
- Macular Pigment Optical Density
- Being tested
- Goji berry, Lutein + zeaxanthin supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goji berryDietary 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.
Lutein + zeaxanthin supplementationDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Dietary Supplement: Lutein + zeaxanthin supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (2)
Skin carotenoids concentration
Skin carotenoid measurement - the carotenoid content in the skin will be measured through a finger-scanning device using reflection spectroscopy (this process does not capture fingerprints) called the Veggie Meter (VM). This noninvasive method of measuring skin carotenoid levels has been validated to reflect plasma carotenoid concentrations.
Measured: 90 days
Gut fermentation measured as the hydrogen content in the breath
Breath Hydrogen measurement - the participant will be asked to do one short exhalation (about 2-3 seconds) into a collection tube. Their breath sample will be analyzed for hydrogen and methane that are produced by fermentation of carbohydrates (including fiber) in the digestive tract.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start10 Jun 2019
- Primary completion28 May 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Pigment Optical DensityStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized paralleled arm clinical trial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983525
- Sponsor's protocol ID
- 1220178
- Status last verified
- Jul 2020
- First submitted
- 7 Jun 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gojiberry Intake (Lycium Barbarium) on Macular Function
- ClinicalTrials.gov ID
- NCT03983525
- Acronym / sponsor ID
- 1220178
- Conditions
- Macular Pigment Optical Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 28 May 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prior to enrollment, all volunteers that meet the initial inclusion and exclusion based on a telephone interview will be asked to participate in a clinical screening visit, which will assess the subject's overall health, and whether the individual meets the inclusion and exclusion criteria. To determine normal eye health, subjects will provide a statement from their optometrist verifying normal functioning. The study will be conducted in the Ragle Human Nutrition Research Center on the UC Davis campus. The participants will be consented into the study. For those who are not familiar with goji berry, a sample tasting will be provided. In addition, each volunteer will be asked to complete a diet and health habits questionnaire. The first study visit will begin on the same day after the screening visit is done.
The study will be a randomized, controlled, parallel arm design with two groups: goji berry or lutein/zeaxanthin (L/Z) supplement. Participants will be randomly assigned to one of the two groups using a block design that will place an approximately similar number of males and females in each group. The randomization will be conducted by an online tool called Research Randomizer.
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 first study visit will occur immediately after consent is completed.
Depending on group assignment, the participant will be provided with either a 45-day supply of goji berries or 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). Participants will complete a log in order to verify compliance. Dietary recall will be collected by using the Automated Self-Administered 24-hour dietary assessment (ASA24) web-based tool between each SV.
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.
Skin carotenoid measurement - the carotenoid content in the skin will be measured through a finger-scanning device using reflection spectroscopy (this process does not capture fingerprints) called the Veggie Meter (VM). This noninvasive method of measuring skin carotenoid levels has been validated to reflect plasma carotenoid concentrations.
Breath Hydrogen measurement - the participant will be asked to do one short exhalation (about 2-3 seconds) into a collection tube. Their breath sample will be analyzed for hydrogen and methane that are produced by fermentation of carbohydrates (including fiber) in the digestive tract.
Compliance will be assessed verbally and through self-reported logs indicating consumption of the product. Dietary recall will be collected by using the Automated Self-Administered 24-hour dietary assessment (ASA24) web-based tool during each study arm, and a weekly log book of digestive tract symptoms, which will record a typical symptom such as bloating, gas, intestinal cramps, and loose stools.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized paralleled arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| Goji berry | Experimental | Dietary Supplement: Goji berryThe 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). |
| Lutein + zeaxanthin supplementation | Active comparator | Dietary Supplement: Lutein + zeaxanthin supplementationThe 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). |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (6 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goji berryThose 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 | Goji berry |
| Lutein + zeaxanthin supplementationThose 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. | Dietary supplement | Lutein + zeaxanthin supplementation |
Primary outcome
Macular pigment ocular density (MPOD)
Time frame: 90 days
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.
2 secondary outcomes
Skin carotenoids concentration
Time frame: 90 days
Gut fermentation measured as the hydrogen content in the breath
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Macular Pigment Optical Density
Recruiting
Lutein, Zeaxathin, and Fish Oil Supplementation
Cognitive Performance, Age-Related Macular Degeneration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goji berry and Lutein + zeaxanthin supplementation in people with Macular Pigment Optical Density, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular pigment ocular density (MPOD) (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.