None listed
Conditions
Brief summary
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.
Interventions
A. Standard FloraGLO Lutein 20mg / day – Proprietary Ingredient ID 12948
B. AquaCelle FloraGLO Lutein 5mg / day – ARTG L 277981
Randomisation 1:1
The investigational products are to be taken at breakfast time with water.
Approximately 62 adult male and female participants aged between 20 and 45 years will be recruited from
databases and public media outlets. Following preliminary screening via telephone, if eligible, potential participants
will attend the clinic for an information session
A. Standard FloraGLO Lutein 20mg / day – Proprietary Ingredient ID 12948 B. AquaCelle FloraGLO Lutein 5mg / day – ARTG L 277981 Randomisation 1:1 The investigational products are to be taken at breakfast time with water. Approximately 62 adult male and female participants aged between 20 and 45 years will be recruited from databases and public media outlets. Following preliminary screening via telephone, if eligible, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a health assessment including lifestyle, current medications, weight and height assessment and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Blood lutein concentration will also be measured. Participants will be given a list of foods to avoid during the study period. Participants will also complete a food diary at baseline, week 8 and 16. The specific foods participants must avoid during the study are: • Spinach, kale, chard, collard greens, mustard greens, lettuce, spring onions, broccoli • Coriander, basil, parsley • Pistachio nuts • More than 3 eggs per week Participants will take the allocated product daily for 16 weeks and undertaken the same baseline measures at weeks 4, 8, 12 and 16. Macular Pigment Optical Density (MPOD) will be measured by the MPS II Macular Pigment Screener (Elecktron Technology) (MPS II). MPS II is a computerised instrument for measuring MPOD. The MPS II emits low intensity light of specific wavelengths at calibrated intensities. The test subject is asked to look into the instrument at the stimulus light and asked to press a button when a light flicker appears.
Sponsors
RDC Global Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
• 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.
Exclusion criteria
• 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
Outcome results
None listed