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Effects of Lutein on Visual Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03113864
Recruitment Status : Terminated (Recruiting Issue)
First Posted : April 14, 2017
Last Update Posted : December 6, 2018
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Kemin Foods LC

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%.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113864


Locations
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United Kingdom
The University of Manchester
Manchester, United Kindgom, United Kingdom, M13 9PL
Sponsors and Collaborators
Kemin Foods LC
DSM Nutritional Products, Inc.
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Responsible Party: Kemin Foods LC
ClinicalTrials.gov Identifier: NCT03113864    
Other Study ID Numbers: 16-004
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Malnutrition
Nutrition Disorders