Effects of Lutein on Visual Function

Sponsor

Kemin Foods LC (Industry)

Overall Status

Terminated

CT.gov ID

NCT03113864

Collaborator

DSM Nutritional Products, Inc. (Industry)

Enrollment

Location

Arms

14.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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	N/A

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%.

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention TrialRandomized, 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 :

Apr 15, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Jun 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

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

Co-primary outcome: Cone Sensitivity Recovery [9 months]
Visual Parameter
Co-primary outcome: Chromatic Contrast Sensitivity [9 months]
Visual Parameter

Secondary Outcome Measures

Dark Adaption [9 months]
Visual Parameter
Macular Pigment Optical Density [9 months]
Visual Parameter
Visual Acuity [9 months]
Visual Parameter
Complement Factor D, C5a, and MAC [9 months]
Inflammatory Marker
Plasma Carotenoid Levels [9 months]
Blood Marker

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

	Site	City	State	Country	Postal Code
1	The University of Manchester	Manchester	United Kindgom	United Kingdom	M13 9PL

Sponsors and Collaborators

Kemin Foods LC
DSM Nutritional Products, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kemin Foods LC

ClinicalTrials.gov Identifier:

NCT03113864

Other Study ID Numbers:

16-004

First Posted:

Apr 14, 2017

Last Update Posted:

Dec 6, 2018

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kemin Foods LC

Additional relevant MeSH terms:

Malnutrition

Study Results

No Results Posted as of Dec 6, 2018