Effects of Lutein on Visual Function

Healthy Clinical Trial

Official title:

Beneficial Effects of Lutein on Visual Function in Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03113864
• Other study ID #: 16-004
• Status: Terminated
• Phase: N/A
• Start date: April 15, 2017
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2017
• Source: Kemin Foods LC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Malnutrition
• Nutrition Poor

Intervention

Dietary Supplement:
• Placebo
Daily supplementation for 9 months
• Lutein
Daily Supplementation for 9 months

Locations

Country	Name	City	State
United Kingdom	The University of Manchester	Manchester	United Kindgom

Sponsors (2)

Lead Sponsor	Collaborator
Kemin Foods LC	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Co-primary outcome: Cone Sensitivity Recovery	Visual Parameter	9 months
Primary	Co-primary outcome: Chromatic Contrast Sensitivity	Visual Parameter	9 months
Secondary	Dark Adaption	Visual Parameter	9 months
Secondary	Macular Pigment Optical Density	Visual Parameter	9 months
Secondary	Visual Acuity	Visual Parameter	9 months
Secondary	Complement Factor D, C5a, and MAC	Inflammatory Marker	9 months
Secondary	Plasma Carotenoid Levels	Blood Marker	9 months