A comparative randomised double blind study to evaluate the effect of Lutein supplementation on Macular Pigment Optical Density (MPOD) and blood Lutein levels in healthy adults over 16 weeks.
- Conditions
- eye health - Macular Pigment Optical Density (MPOD)Eye - Normal eye development and function
- Registration Number
- ACTRN12618000276257
- Lead Sponsor
- RDC Global Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 62
•Men and women between the ages of 20 and 45 years
•Non-smoker (for 1 year)
•BMI 18.5-30.0
•No chronic diseases or gastrointestinal disturbances
•No prescription or over-the-counter drugs during the study (except oral contraceptive pill OCP), or vitamin or mineral supplements containing carotenoids/B-Carotene
•Agree to maintain current dietary habits throughout the duration of the study.
•MPOD values between 0.1-0.3
•No history or evidence of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haemotogical abnormalities that are uncontrolled.
•Participant’s full agreement and ability to consent to participation in the study
•Participant’s ability to participate fully and comply with demands of the study including attendance at all scheduled blood collection time points.
•A regular consumer (greater or equal to 2 servings/week) of lutein rich foods or lutein supplements
•Uncontrolled hypertension (>140/90 mm Hg)
•Diabetes mellitus
•Pregnancy (or planning to become pregnant) or lactation
•Diseases that interfere with fat absorption, e.g. colitis, celiac disease, Crohn’s disease, cystic fibrosis
•Eye conditions, cataracts, glaucoma
•Reported participation in another trial 3 months before the start of the study
•Recent history (within 12 months) of substance abuse including alcohol
•Current smoker
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Macular Pigment Optical Density (MPOD) as measured by the MPSII Macular Lutein Pigment Screener [Baseline, week 4, 8, 12 and 16 (primary timepoint)]
- Secondary Outcome Measures
Name Time Method Blood Lutein concentration (plasma / serum)[Baseline, weeks 4, 8, 12 and 16];Gastrointestinal tolerance as measured using the Gastrointestinal tolerance questionnaire [Baseline, week 4, 8, 12 and 16];Food intake measured by food diary [Baseline, weeks 8 and 16];Weight and height to be used to calculate BMI[Baseline, weeks 4, 8, 12 and 16]