Back to resultsEffects of Lutein on Visual Function
Primary Purpose
Healthy, Nutrition Poor
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
Lutein
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring Vision, Eye Health, Lutein, Carotenoids
Eligibility Criteria
Inclusion Criteria:
- Men and women age 40-60 years
- Corrected Visual Acuity of 20/20 to 20/25
- MPOD 0.05- 0.30 OD units
- Must be able to give written informed consent in English
- BMI < or = 30 kg/m2
- Subject is willing to maintain a habitual diet and physical activity patterns throughout the study period
Exclusion Criteria:
- Use of carotenoid, fish oil, or n-3 fatty acid supplements (within 2 months of study start)
- Ocular pathologies
- History of active small bowel disease or resection
- Uncontrolled hypertension
- Diabetes mellitus
- Pancreatic disease
- Pregnancy (or planning to become pregnant) or lactation
- Diseases that interfere with fat absorption
- Medication or supplements that contain a significant level of carotenoids
- Medications that interfere with fat absorption
- Use of drugs suspected of interfering with metabolism of blood clotting
- Chronic alcohol intake
- Stroke, head injury with loss of consciousness or seizures
- Severe Amblyopia resulting in visual acuity worse than 0.4 MAR
- Subject is a heavy smoker (> 1 pack/day)
- A regular consumer of lutein rich foods or lutein supplements
- A regular consumer of foods high in DHA intake or DHA supplements
- Subject has donated more than 300 mL of blood during the last three months prior to screening
Sites / Locations
- The University of Manchester
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Lutein
Arm Description
Will be identical looking to treatment
10 mg of FloraGLO Lutein
Outcomes
Primary Outcome Measures
Co-primary outcome: Cone Sensitivity Recovery
Visual Parameter
Co-primary outcome: Chromatic Contrast Sensitivity
Visual Parameter
Secondary Outcome Measures
Dark Adaption
Visual Parameter
Macular Pigment Optical Density
Visual Parameter
Visual Acuity
Visual Parameter
Complement Factor D, C5a, and MAC
Inflammatory Marker
Plasma Carotenoid Levels
Blood Marker
Full Information
NCT ID
NCT03113864
First Posted
March 15, 2017
Last Updated
December 4, 2018
Sponsor
Kemin Foods LC
Collaborators
DSM Nutritional Products, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03113864
Brief Title
Effects of Lutein on Visual Function
Official Title
Beneficial Effects of Lutein on Visual Function in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruiting Issue
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kemin Foods LC
Collaborators
DSM Nutritional Products, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized, double blind, placebo-controlled intervention trial on the ocular benefits and inflammatory markers improvements of taking FloraGLO Lutein for 9 months. The population of interest is middle-aged men and women who have low levels of carotenoids in their eyes.
Detailed Description
The participants will be given a brief explanation of the study and asked to sign an informed consent form. During the screening visit, pre-study parameters will be measured in order to assess the subjects' eligibility to participate.
These include:
Medical History
Vital signs, Height and weight and BMI calculation
Visual Parameters
Blood draw for clinical chemistry and hematological safety
Intervention Period:
At baseline visual parameters and a serum sample for analysis of inflammatory markers will be taken. Supplements will be dispensed. Study visits will then be conducted every 3 months. At these visits, subjects will have visual parameters, adverse events, study diary, vitals, a questionnaire evaluating health/diet/exercise/alcohol, product distribution and compliance checked. A final serum/plasma sample will be taken at the final visit for re-assessment of safety parameters and inflammatory markers.
Compliance check:
The number of tablets dispensed at baseline and returned, as well as all intake information from a subject diary. Per protocol population is defined apriori as >80%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Nutrition Poor
Keywords
Vision, Eye Health, Lutein, Carotenoids
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All parties involved in the study are blinded
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Will be identical looking to treatment
Arm Title
Lutein
Arm Type
Experimental
Arm Description
10 mg of FloraGLO Lutein
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Daily supplementation for 9 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Lutein
Intervention Description
Daily Supplementation for 9 months
Primary Outcome Measure Information:
Title
Co-primary outcome: Cone Sensitivity Recovery
Description
Visual Parameter
Time Frame
9 months
Title
Co-primary outcome: Chromatic Contrast Sensitivity
Description
Visual Parameter
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Dark Adaption
Description
Visual Parameter
Time Frame
9 months
Title
Macular Pigment Optical Density
Description
Visual Parameter
Time Frame
9 months
Title
Visual Acuity
Description
Visual Parameter
Time Frame
9 months
Title
Complement Factor D, C5a, and MAC
Description
Inflammatory Marker
Time Frame
9 months
Title
Plasma Carotenoid Levels
Description
Blood Marker
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women age 40-60 years
Corrected Visual Acuity of 20/20 to 20/25
MPOD 0.05- 0.30 OD units
Must be able to give written informed consent in English
BMI < or = 30 kg/m2
Subject is willing to maintain a habitual diet and physical activity patterns throughout the study period
Exclusion Criteria:
Use of carotenoid, fish oil, or n-3 fatty acid supplements (within 2 months of study start)
Ocular pathologies
History of active small bowel disease or resection
Uncontrolled hypertension
Diabetes mellitus
Pancreatic disease
Pregnancy (or planning to become pregnant) or lactation
Diseases that interfere with fat absorption
Medication or supplements that contain a significant level of carotenoids
Medications that interfere with fat absorption
Use of drugs suspected of interfering with metabolism of blood clotting
Chronic alcohol intake
Stroke, head injury with loss of consciousness or seizures
Severe Amblyopia resulting in visual acuity worse than 0.4 MAR
Subject is a heavy smoker (> 1 pack/day)
A regular consumer of lutein rich foods or lutein supplements
A regular consumer of foods high in DHA intake or DHA supplements
Subject has donated more than 300 mL of blood during the last three months prior to screening
Facility Information:
Facility Name
The University of Manchester
City
Manchester
State/Province
United Kindgom
ZIP/Postal Code
M13 9PL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Lutein on Visual Function
We'll reach out to this number within 24 hrs