ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Macular degeneration risk

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Eye

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]

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]

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]

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]

Bioavailability of lutein and Zeaxanthin supplements based on serum levels with and without omega 3 supplement.

Timepoint [2]

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]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment postcode(s) [1]

2052 - Unsw Sydney

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of New South Wales

Address [1]

Director, Research Ethics and Compliance Support, UNSW Sydney, NSW 2052 Australia

Country [1]

Australia

Funding source category [2]

University

Name [2]

UNSW Sydney

Address [2]

School of Chemical Engineering
Building E8, Science and Engineering Building
UNSW Sydney, NSW 2052

Country [2]

Australia

Primary sponsor type

University

Name

UNSW

Address

Research Ethics and Compliance Support, UNSW Sydney
NSW 2052 Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNSW Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Research Ethics and Compliance Support (RECS), Research Division, UNSW
Sydney, NSW 2052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

11/10/2021

Approval date [1]

15/10/2021

Ethics approval number [1]

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

A/Prof Jayashree Arcot

Address

Food and Health
School of Chemical Engineering
E8, Science and Engineering Building
UNSW Sydney
NSW 2052 Australia

Country

Australia

Phone

+6129385 5360

Fax

j.arcot@unsw.edu.au

Contact person for public queries

Name

Charles W McMonnies

Address

School of Optometry and Vision Science,
Faculty of Medicine and Health, UNSW Sydney,
NSW 2052.

Country

Australia

Phone

+61 2 9958 3046

Fax

c.mcmonnies@unsw.edu.au

Contact person for scientific queries

Name

Jayashree Arcot

Address

Food and Health
School of Chemical Engineering
E8, Science and Engineering Building
UNSW Sydney
NSW 2052 Australia

Country

Australia

Phone

+6129385 5360

Fax

j.arcot@unsw.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

Trial Review

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