Effects of Lutein on Visual Function

• ClinicalTrials.gov Identifier: NCT03113864
• Recruitment Status: Terminated
• First Posted: April 14, 2017
• Last Update Posted: December 6, 2018
• Sponsor: Kemin Foods LC
• Collaborator: DSM Nutritional Products, Inc.
• Information provided by (Responsible Party): Kemin Foods LC

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.

Condition or disease	Intervention/treatment	Phase
Healthy; Nutrition Poor	Dietary Supplement: Placebo; Dietary Supplement: Lutein	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention Trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: All parties involved in the study are blinded
• Primary Purpose: Prevention
• Official Title: Beneficial Effects of Lutein on Visual Function in Healthy Subjects
• Actual Study Start Date: April 15, 2017
• Actual Primary Completion Date: June 30, 2018
• Actual Study Completion Date: June 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Co-primary outcome: Cone Sensitivity Recovery [ Time Frame: 9 months ]
   Visual Parameter
2. Co-primary outcome: Chromatic Contrast Sensitivity [ Time Frame: 9 months ]
   Visual Parameter

Secondary Outcome Measures :

1. Dark Adaption [ Time Frame: 9 months ]
   Visual Parameter
2. Macular Pigment Optical Density [ Time Frame: 9 months ]
   Visual Parameter
3. Visual Acuity [ Time Frame: 9 months ]
   Visual Parameter
4. Complement Factor D, C5a, and MAC [ Time Frame: 9 months ]
   Inflammatory Marker
5. Plasma Carotenoid Levels [ Time Frame: 9 months ]
   Blood Marker

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United Kingdom

The University of Manchester

Manchester, United Kindgom, United Kingdom, M13 9PL

Sponsors and Collaborators

Kemin Foods LC

DSM Nutritional Products, Inc.

More Information

• Responsible Party: Kemin Foods LC
• ClinicalTrials.gov Identifier: NCT03113864
• Other Study ID Numbers: 16-004
• First Posted: April 14, 2017
• Last Update Posted: December 6, 2018
• Last Verified: April 2017

Individual Participant Data (IPD) Sharing Statement:

• 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 Kemin Foods LC:

Vision; Eye Health; Lutein; Carotenoids

Additional relevant MeSH terms:

Malnutrition; Nutrition Disorders