age-related macular degeneration (AMD)
Conditions
Interventions
The study will start with a three weeks run-in period for all participants, as
usually has been done when studying lutein and other carotenoid
bioavailability. During the whole study, subjects will
Sponsors
Newtricious b.v.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: age 18-35 years BMI 18-25 kg/m2 body weight should be stable for >=6 months (with no weight gain/loss > 3 kg)
Exclusion criteria
Exclusion criteria: not willing to discontinue consumption of vitamin supplements allergic to cow milk / dairy products/ eggs/ egg-rich products vegetarians pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lutein serum concentrations will be measured before and after the three weeks run-in period and after finishing the whole treatment. Each blood sample will be taken in duplicate, meaning that a repeated sample will be taken from each subjects with a lag time of two days for every time point. Thus, in total 6 blood samples will be drawn during the 9 weeks of the study: t=1, t=3; t=19, t=21; and t=61, t= 63days (table 3). Blood will be drawn by venapunction. Luteine will be measured using high performance liquid chromatography (HPLC). 10% of all plasma measurements will be performed in duplicate, and all samples of a subject will be analyzed in a single session. Zeaxanthin serum concentration can be seen as a control for compliance concerning the dietary guideline to avoid lutein-rich foods, as lutein and zeaxanthin are found in a stable ratio in foods, whereas zeaxanthin is not part of the test beverage. Zeaxanthin will be measured using high performance liquid chromatography (HPLC ). | — |
Secondary
| Measure | Time frame |
|---|---|
| At the end of the study a short questionnaire will be filled in by the volunteer to ask about the product they consumed. Body weight and length Body weight and length will be measured at the start and at the end of the study the bodyweight will be measure to assure no difference in bodyweight. Plasma lipids Plasma cholesterol levels will be measured after the washout period (day21) and at the end of the treatment (day 63) to investigate if the lutein-enriched egg-yolk containing beverage had no effect on blood cholesterol levels when consumed for 35 days. In an earlier study it was suggested that one egg/day increases blood cholesterol levels after 12 weeks, which was not observed when the egg-yolk was incorporated into a milk containing beverage. | — |
Countries
Netherlands
Outcome results
None listed