Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000837729
Ethics application status
Approved
Date submitted
24/03/2022
Date registered
15/06/2022
Date last updated
15/06/2022
Date data sharing statement initially provided
15/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do omega-3 fatty acids affect the absorption of lutein and zeaxanthin in humans?
Scientific title
Effect of omega-3-fatty acid addition to lutein and zeaxanthin supplement and their bioavailability in humans
Secondary ID [1] 305077 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Macular degeneration risk 325856 0
Condition category
Condition code
Diet and Nutrition 320864 320864 0 0
Other diet and nutrition disorders
Eye 323291 323291 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 322648 0
Prevention
Comparator / control treatment
The control group will be provided with L+ Z supplements (10mg + 2mg) on day 1, to be consumed till day 12. Participants will provide blood on day 1 (end of wash-out), day 6 and 12. Low carotenoid and omega 3 fatty acid diets will be continued with a food record maintained throughout the study period along with a 24-hour dietary recall, which will be completed at baseline and after the 12-day period. Food consumed within this period will be recorded by the participants using an online system and monitored in real-time by the researchers.
Prior to the blood collections at baseline (DAY 1), end of wash-out period (DAY 6) and during the intervention on day 6 and 12, participants will be sent text messages and or emails as a reminder 24 hours prior and a follow-up message after the blood collection to check for any discomfort due to the blood collections.
.
Control group
Dose comparison

Outcomes
Primary outcome [1] 330298 0
Changes in serum lutein and zeaxanthin levels as an indicator of absorption/bioavailability in the presence or absence of omega-3 fatty acid supplements.
Timepoint [1] 330298 0
Observed changes in mean serum lutein and zeaxanthin status on day 1, 6, 12 and 20 days post-intervention commencement (end of intervention) during the wash-out and intervention as result of taking lutein and zeaxanthin supplements along with omega-3 fatty acid supplements compared to the control group.
For this, fasting blood will be collected from all participants on Day 1, 6, 12 and 20 post-intervention commencement in both groups
Primary outcome [2] 330878 0
Bioavailability of lutein and Zeaxanthin supplements based on serum levels with and without omega 3 supplement.
Timepoint [2] 330878 0
Fasting blood will be collected on Day 1, 6, 12 and 20 post-intervention commencement from all participants. Serum levels of lutein and Zeaxanthin for all participants on Day 1, 6, 12 and 20 post-intervention commencement and RBC levels of omega 3 fatty acids for the intervention group on Day 6, 12 and 20 post-intervention commencement will be analysed for bioavailability calculations.
Secondary outcome [1] 405627 0
Changes in oxidative stress levels in the serum for all participants will be analysed using standard kits for measurements to compare the effect of omega 3 addition in the intervention group relative to the control group.
Timepoint [1] 405627 0
Oxidative stress levels before and as soon as possible (within a month) after intervention is completed will be measured.

Eligibility
Key inclusion criteria
Healthy volunteers with no known disease conditions
Minimum age
19 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-availability
Statistical methods / analysis
1. Mean dietary intakes of lutein, Zeaxanthin and omega 3 fatty acids will be determined before and after the wash out period. Significant differences between subjects will be determined using a student's t-test.
2. Mean dietary intake will be determined against supplement dosage and serum carotenoids concentration at baseline (day 1) to day 12 and compared using a T-test, analysis of variance (ANOVA), and area under the curve (AUC) to determine the bioavailability of lutein and Zeaxanthin in the presence and absence of omega 3 fatty acids.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/12/2021
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
21/10/2022
Actual
Sample size
Target
60
Accrual to date
18
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 36520 0
2052 - Unsw Sydney

Funding & Sponsors
Funding source category [1] 309477 0
University
Name [1] 309477 0
University of New South Wales
Country [1] 309477 0
Australia
Funding source category [2] 311134 0
University
Name [2] 311134 0
UNSW Sydney
Country [2] 311134 0
Australia
Primary sponsor type
University
Name
UNSW
Address
Research Ethics and Compliance Support, UNSW Sydney
NSW 2052 Australia
Country
Australia
Secondary sponsor category [1] 312476 0
None
Name [1] 312476 0
Address [1] 312476 0
Country [1] 312476 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309264 0
UNSW Human Research Ethics Committee
Ethics committee address [1] 309264 0
Human Research Ethics Committee
Research Ethics and Compliance Support (RECS), Research Division, UNSW
Sydney, NSW 2052
Ethics committee country [1] 309264 0
Australia
Date submitted for ethics approval [1] 309264 0
11/10/2021
Approval date [1] 309264 0
15/10/2021
Ethics approval number [1] 309264 0
HC210655

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113546 0
A/Prof Jayashree Arcot
Address 113546 0
Food and Health
School of Chemical Engineering
E8, Science and Engineering Building
UNSW Sydney
NSW 2052 Australia
Country 113546 0
Australia
Phone 113546 0
+6129385 5360
Fax 113546 0
Email 113546 0
[email protected]
Contact person for public queries
Name 113547 0
Prof Charles W McMonnies
Address 113547 0
School of Optometry and Vision Science,
Faculty of Medicine and Health, UNSW Sydney,
NSW 2052.
Country 113547 0
Australia
Phone 113547 0
+61 2 9958 3046
Fax 113547 0
Email 113547 0
[email protected]
Contact person for scientific queries
Name 113548 0
A/Prof Jayashree Arcot
Address 113548 0
Food and Health
School of Chemical Engineering
E8, Science and Engineering Building
UNSW Sydney
NSW 2052 Australia
Country 113548 0
Australia
Phone 113548 0
+6129385 5360
Fax 113548 0
Email 113548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.