MP-GD: Macular Pigment and Glare Disability

• Sponsor: University of Georgia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00909090
• Collaborator: DSM Nutritional Products, Inc. (Industry)
• Enrollment: 109
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of this study is:

1. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.

2. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions.

3. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.

4. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.

Condition or Disease	Intervention/Treatment	Phase
Vision, Entoptic	Dietary Supplement: 12 mg Lutein + Zeaxanthin; Dietary Supplement: Visually identical placebo	N/A

Detailed Description

The following measurements will be taken, before and after supplementation with lutein and zeaxanthin:

Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 109 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two arms: nutritional supplement vs. placebo.Two arms: nutritional supplement vs. placebo.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin	Dietary Supplement: 12 mg Lutein + Zeaxanthin; 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year; Other Names: FloraGlo lutein + OptiSharp zeaxanthin
Placebo Comparator: Placebo visually identical placebo	Dietary Supplement: Visually identical placebo; Visually identical placebo, taken once daily for one year

Outcome Measures

Primary Outcome Measures

1. Macular Pigment Optical Density [every three months for one year; 12-month measure reported.]

   optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity

Secondary Outcome Measures

1. Glare Disability [12-month data point only]

   light energy needed to obscure or veil a visual target; calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.

2. Photostress Recovery Time [improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)]

   amount of time needed to recover from exposure to a bright light, and to regain sight of a visual target

3. Heterochromatic Contrast Sensitivity [12-month data point only]

   amount of short-wave light energy necessary to obscure of veil a visual target, calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Gender: male or female

• Age: 18 - 40 years

• BMI: 20-30

• No anticipated changes in dieting habits (as relevant to xanthophyll intake).

• No anticipated surgical procedures.

• Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.

• Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.

• Corrected visual acuity (ETDRS): better than 20/60

Exclusion Criteria:

• BMI <20 or >30

• Age <18 or >40 years

• Smokers

• Current or history of relevant diseases (such as AMD)

• Corrected visual acuity worse than 20/60

• Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.

• Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.

• Current use of xanthophyll containing supplements

• Use of xanthophyll containing supplements in the past 6 months

• Participation in any other study during last 1 month.

• Blood donation during the last 3 months.

• Known hypersensitivity or allergy to xanthophylls.

• Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.

• Suspected lack of compliance with any requirements of the study.

• Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).

• Current pregnancy or breast feeding

• Any relevant abnormalities in the routine laboratory tests

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vision Sciences Laboratory, UGA	Athens	Georgia	United States	30602

Sponsors and Collaborators

• University of Georgia
• DSM Nutritional Products, Inc.

Investigators

• Principal Investigator: Billy R Hammond, Ph.D., University of Georgia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Billy R. Hammond, Professor, University of Georgia
• ClinicalTrials.gov Identifier: NCT00909090
• Other Study ID Numbers: UGA-2009-10141-1
• First Posted: May 27, 2009
• Last Update Posted: Jul 13, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Billy R. Hammond, Professor, University of Georgia: macular pigment; glare disability; lutein; photostress; chromatic contrast sensitivity

Study Results

Participant Flow

Recruitment Details	Recruitment was initiated in May, 2009. The enrollment period was rolling and lasted for 30 months. Enrollment closed in November, 2011. Participants were recruited from the local Athens, Clarke-County community and the University of Georgia student population.
Pre-assignment Detail	Key events: Telephone screening to confirm eligibility Enrollment Randomization

Arm/Group Title	Intervention	Placebo
Arm/Group Description	10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Period Title: Overall Study
STARTED	53	56
COMPLETED	36	39
NOT COMPLETED	17	17

Baseline Characteristics

Arm/Group Title	12 mg Lutein + Zeaxanthin	Visually Identical Placebo	Total
Arm/Group Description	10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	visually identical placebo Placebo: Visually identical placebo, taken once daily for one year	Total of all reporting groups
Overall Participants	53	56	109
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	23.7 (4.61)	22.7 (3.32)	23.2 (3.97)
Sex/Gender, Customized (Count of Participants)
Male	22 41.5%	22 39.3%	44 40.4%
Female	31 58.5%	34 60.7%	65 59.6%
Region of Enrollment (participants) [Number]
United States	53 100%	56 100%	109 100%
BMI (kg/cm^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/cm^2]	22.9 (2.45)	22.8 (2.66)	22.85 (2.56)
Iris Darkness (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.90 (1.31)	2.81 (1.27)	2.86 (1.29)

Outcome Measures

1. Primary Outcome

Title	Macular Pigment Optical Density
Description	optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity
Time Frame	every three months for one year; 12-month measure reported.

Outcome Measure Data

Analysis Population Description

Participants who completed all four measurements

Arm/Group Title	Luten + Zeaxanthin	Placebo
Arm/Group Description	10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Measure Participants	36	39
Mean (Standard Deviation) [optical density]	0.54 (0.10)	0.42 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Luten + Zeaxanthin, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Glare Disability
Description	light energy needed to obscure or veil a visual target; calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.
Time Frame	12-month data point only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Placebo
Arm/Group Description	10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Measure Participants	36	39
Mean (Standard Deviation) [log relative energy]	1.81 (0.10)	1.83 (0.11)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Luten + Zeaxanthin, Placebo
	Comments	Analysis compared mean differences between placebo and intervention at the 12-month time point.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.21
	Comments
	Method	Regression, Linear
	Comments

3. Secondary Outcome

Title	Photostress Recovery Time
Description	amount of time needed to recover from exposure to a bright light, and to regain sight of a visual target
Time Frame	improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	12 mg Lutein + Zeaxanthin	Visually Identical Placebo
Arm/Group Description	10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Measure Participants	36	39
Mean (Standard Deviation) [seconds]	10.5 (7.5)	4.5 (6.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Luten + Zeaxanthin, Placebo
	Comments	Analysis compared mean change from baseline to 12-month time points.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	t-test, 1 sided
	Comments

4. Secondary Outcome

Title	Heterochromatic Contrast Sensitivity
Description	amount of short-wave light energy necessary to obscure of veil a visual target, calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.
Time Frame	12-month data point only

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	12 mg Lutein + Zeaxanthin	Visually Identical Placebo
Arm/Group Description	10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year	visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
Measure Participants	36	39
Mean (Standard Deviation) [log relative energy]	1.21 (0.14)	1.16 (0.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Luten + Zeaxanthin, Placebo
	Comments	analysis conducted on mean change over one year, between groups
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	One year
Adverse Event Reporting Description	Adverse event collection occurred over the phone at one month intervals, and during in-person follow-up visits every three months.
Arm/Group Title	Intervention		Placebo
Arm/Group Description	10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year		visually identical placebo Placebo: Visually identical placebo, taken once daily for one year
All Cause Mortality
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/56 (0%)
Serious Adverse Events
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/56 (0%)

Limitations/Caveats

Sample included only young, healthy adults with acute vision. Because the sample was recruited from the local college student population, there were high rates of attrition (students moving away, forgetting appointments, discontinuing contact)

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.