Effects of Lutein on Visual Function

NCT ID: NCT03113864

Last Updated: 2018-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-15
• Study Completion Date: 2018-06-30

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:

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%.

Conditions

Healthy; Nutrition Poor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Will be identical looking to treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Daily supplementation for 9 months

Lutein

10 mg of FloraGLO Lutein

Group Type: EXPERIMENTAL

Lutein

Intervention Type: DIETARY_SUPPLEMENT

Daily Supplementation for 9 months

Interventions

Placebo

Daily supplementation for 9 months

Intervention Type: DIETARY_SUPPLEMENT

Lutein

Daily Supplementation for 9 months

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

Kemin Foods LC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Manchester

Manchester, United Kindgom, United Kingdom

Countries

United Kingdom

Other Identifiers

16-004

Identifier Type: -

Identifier Source: org_study_id