Effects of Lutein on Visual Function

Beneficial Effects of Lutein on Visual Function in Healthy Subjects

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.

Study Overview

• Status: Terminated
• Conditions: Healthy; Nutrition Poor
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lutein

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:

1. Medical History
2. Vital signs, Height and weight and BMI calculation
3. Visual Parameters
4. 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%.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • United Kindgom
    • Manchester, United Kindgom, United Kingdom, M13 9PL
      • The University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Will be identical looking to treatment	Dietary supplement: Placebo; Daily supplementation for 9 months
Experimental: Lutein; 10 mg of FloraGLO Lutein	Dietary supplement: Lutein; Daily Supplementation for 9 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-primary outcome: Cone Sensitivity Recovery	Visual Parameter	9 months
Co-primary outcome: Chromatic Contrast Sensitivity	Visual Parameter	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dark Adaption	Visual Parameter	9 months
Macular Pigment Optical Density	Visual Parameter	9 months
Visual Acuity	Visual Parameter	9 months
Complement Factor D, C5a, and MAC	Inflammatory Marker	9 months
Plasma Carotenoid Levels	Blood Marker	9 months

Collaborators and Investigators

• Sponsor: Kemin Foods LC
• Collaborators: DSM Nutritional Products, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: December 4, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Vision; Carotenoids; Lutein; Eye Health
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition
• Other Study ID Numbers: 16-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No