None listed
Conditions
Brief summary
Baseline data will be obtained from consenting participants at the first screening visit before enrolment into the study. This will occur after eligible participants aged 19 -65 years have expressed interest via e-mail in participating in this study. Participants will be screened using an online demographic characteristics questionnaire (age in years, gender status, ethnicity, family history of AMD, bowel, atrophic, cardiovascular, pancreatic disorders, diabetes and gastrointestinal disease, current or recent supplement use, smoking status, alcohol intake, current or recent use of medications that may affect lipid absorption, currently on a medically related special diet) will be collected. While physical activity level including body mass index and fat will be determined using a body composition analyzer. Initial venous blood sample (20ml) for estimating lutein and zeaxanthin (using high performance liquid chromatography) and omega 3 fatty acids (using gas chromatography – mass spectrometry) including the oxidative stress level (using flow cytometry, a tool used for single cell analysis of immune system) will be collected. Other information on the history of bowel disease, cardiovascular disease, hepatic, diabetes, gastrointestinal or renal disease will be assessed. Anthropometric indices (height, weight, body mass index) will be obtained. After collection of baseline data, study participants will commence a 6-day wash-out. Within this period, they will follow a low carotenoid-omega-3-diet based on the list of foods provided and provide venous blood (day 1 and 7). Participants will be contacted once every week via text/e-mail during the wash-out period to ensure they follow the low carotenoids and omega 3 fatty acid diet. If any participants were not compliant with the low carotenoid and omega 3 fatty acid diets, the wash-out period will either be extended for another week or discontinued from the study. On completing the 7-day wash-out period, participants will commence a 12-day intervention. The control group will receive L+Z supplement and the intervention group will receive L+Z and omega-3-supplements. The changes in lutein and zeaxanthin levels in the blood after the intervention will be recorded; the area under the curve for serum levels of lutein and zeaxanthin with and without omega 3 supplementation will be used for calculation of bioavailability.
Interventions
Participants of the intervention group of this study will be provided with oral supplements (tablets and capsules) containing lutein (10mg), zeaxanthin (2mg) and omega-3-EFA (540mg + 360mg EPA/DHA) to be taken daily for oral consumption. Participants will provide blood on day 1(end of wash-out), day 6 and 12.
Participants will be contacted once or twice during the study (once during the wash-out period 1-6 days) and another time during the intervention (6-12 days) just through a 2 minute phone
Participants of the intervention group of this study will be provided with oral supplements (tablets and capsules) containing lutein (10mg), zeaxanthin (2mg) and omega-3-EFA (540mg + 360mg EPA/DHA) to be taken daily for oral consumption. Participants will provide blood on day 1(end of wash-out), day 6 and 12. Participants will be contacted once or twice during the study (once during the wash-out period 1-6 days) and another time during the intervention (6-12 days) just through a 2 minute phone call to motivate them to follow a low carotenoid and omega 3 fatty acid diet, a food list consisting of low carotenoid and omega-3-EFA diet extracted from USDA food composition database (“< 6mg”) and providing them with a list of foods to avoid. Foods consumed within this period will be recorded by the participants online. On Day 12, at the end of the intervention study, participants will complete a 24-hour dietary survey using the online ASA 24 dietary assessment tool (https://epi.grants.cancer.gov/asa24/). Dietary intakes will be recorded for checking compliance of low lutein, zeaxanthin and omega 3 fatty acid intakes through their daily diets throughout the study and return of the oral supplements at the end of the study to check for compliance of intake of supplements during the intervention period. Text messages and/or emails will be sent to each participant as a reminder within 24 hours of the next blood collection and a follow-up message to check for any discomfort due to the blood collections
Sponsors
UNSW
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers with no known disease conditions
Exclusion criteria
1. lack of sufficient English fluency 2. unwillingness to participate. 3. inability to give informed consent. 4. participants with history of bowel atrophic conditions, gastritis, diabetes, pancreatic bleeding disorder 5. participants on medically related special diets already 6. participants with history of smoking or alcoholism 7. current or recent (last 2 months) use of medications that may affect lipid absorption (i.e antibiotics) or vitamin supplement. 8. current or recent (last 6 months) use of carotenoid supplements
Outcome results
None listed