utein and Mental Acuity Study II: an assessment of lutein and systemic factors that impact cognitive function

OmniActive Health Technologies Inc0 个研究点目标入组 60 人开始时间: 2016年3月30日最近更新: 2018年8月20日

适应症

试验速览

•Participants will be asked to complete a short questionnaire to determine eligibility for the study. Questions are related to the exclusionary criteria” noted above (subject’s smoking status, body-mass index, pregnancy status, nutritional supplementation status (esp. lutein or zeaxanthin), eye disease status, and potential digestive issues

•1. Body Mass Index of 27 or greater. In an overweight individual, the supplemental lutein may be deposited preferentially in adipose tissue, and not in the retina
•2. Macular pigment optical density (MPOD) of 0.70 or higher. Individuals with very high MPOD may be approaching saturation levels, and therefore not exhibit changes reflective of lutein supplementation. They would therefore be excluded from the study. The 0.70 criterion is a level from which subjects can typically increase appreciably upon supplementation
•3. Ocular disease or insufficient visual acuity. Subjects will undergo an initial visual screening, and if either of these situations is evident, the subject will be excluded from the study. Visual acuity of 20/30 best corrected is cutoff for exclusion
•4. Systemic disease. If a subject is currently in a disease state (e.g. diabetes), then s(he) will be precluded from participating the study
•5. Smoking status. Current smokers will be excluded from the study. Smoking has been shown to have deleterious systemic health effects, and (germane to our proposal) is inversely related to MPOD level. The ability of smokers to accumulate supplemented lutein in the retina could be compromised
•6. Psychiatric medication. Individuals currently taking medication to treat a psychiatric condition (e.g. obsessive-compulsive disorder) will not be enrolled in the study

发起方