Effects of Lutein on Visual Function

NCT03113864 | Terminated

• 1 other identifier: 16-004
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Nutrition Poor

Keywords

Vision; Eye Health; Lutein; Carotenoids

Outcome Measures

Primary Outcomes (2)

• Co-primary outcome: Cone Sensitivity Recovery

  Visual Parameter

  9 months

• Co-primary outcome: Chromatic Contrast Sensitivity

  Visual Parameter

  9 months

Secondary Outcomes (5)

• Dark Adaption

  9 months

• Macular Pigment Optical Density

  9 months

• Visual Acuity

  9 months

• Complement Factor D, C5a, and MAC

  9 months

• Plasma Carotenoid Levels

  9 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Will be identical looking to treatment

Dietary Supplement: Placebo

Lutein

EXPERIMENTAL

10 mg of FloraGLO Lutein

Dietary Supplement: Lutein

Interventions

Placebo DIETARY_SUPPLEMENT

Daily supplementation for 9 months

Placebo

Lutein DIETARY_SUPPLEMENT

Daily Supplementation for 9 months

Lutein

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kemin Foods LC: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

The University of Manchester

Manchester, United Kindgom, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Lutein

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Xanthophylls; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties involved in the study are blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention Trial

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: April 14, 2017
• Study Start: April 15, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 6, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)