Clinical trial NCT03113864: Effects of Lutein on Visual Function
Official title: Beneficial Effects of Lutein on Visual Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Nutrition Poor
Keywords: Vision
Eye Health
Lutein
Carotenoids
Lead sponsor: Kemin Foods LC
Sponsor class: INDUSTRY
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2017-04-14
Enrollment: 14
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Parallel Intervention Trial
Primary purpose: PREVENTION

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%.

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

Primary outcomes:
measure: Co-primary outcome: Cone Sensitivity Recovery
timeFrame: 9 months
measure: Co-primary outcome: Chromatic Contrast Sensitivity
timeFrame: 9 months
Secondary outcomes:
measure: Dark Adaption
timeFrame: 9 months
measure: Macular Pigment Optical Density
timeFrame: 9 months
measure: Visual Acuity
timeFrame: 9 months
measure: Complement Factor D, C5a, and MAC
timeFrame: 9 months
measure: Plasma Carotenoid Levels
timeFrame: 9 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The University of Manchester
state: United Kindgom
Study officials:
References: