Beneficial Effects of Lutein on Visual Function in Healthy Subjects
| Registry | NCT03113864 |
|---|---|
| Status | Terminated - Recruiting Issue |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: quadruple, prevention |
| Enrollment | 14 (Actual) |
| Sponsor | Kemin Foods LC (Industry); collaborators: dsm-firmenich Switzerland AG |
| Conditions | Healthy, Nutrition Poor |
| Interventions | Placebo, Lutein (Dietary supplement) |
| Dates | start 2017-04-15, primary completion 2018-06-30, completion 2018-06-30, first posted 2017-04-14, last updated 2018-12-06 |
| Locations | 1 site in United Kingdom |
Related Papers Related Patents Related Grants Related Experts
All trials for Healthy All trials for Nutrition Poor All trials of Placebo All trials of Lutein
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.
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%.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Placebo | Will be identical looking to treatment |
| Lutein | Experimental | Dietary Supplement: Lutein | 10 mg of FloraGLO Lutein |
Sex: All, ages: 40 Years to 60 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| The University of Manchester | Manchester, United Kindgom | United Kingdom |