ProFiLE human bioavailability trial: Lutein bioavailability from a lutein-fortified sports beverage and a lutein-fortified cupcake
| ISRCTN | ISRCTN13108633 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13108633 |
- Submission date
- 15/05/2025
- Registration date
- 11/08/2025
- Last edited
- 11/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
The Nutrition Research Centre Ireland (NRCI), based at the Southeast Technological University (SETU), is presently engaged in investigating the potential of lutein-enriched functional foods to effectively introduce lutein into the human body. This investigation was carried out by the NRCI through a bioavailability study in collaboration with Cybercolors Ltd (Fermoy, Ireland). Lutein is a micronutrient naturally found in various fruits and vegetables. It is a vital component of a balanced diet and has been scientifically proven to enhance both visual and cognitive function, with positive benefits for age-related macular degeneration (AMD), the world’s leading cause of blindness. The human body cannot produce lutein on its own, and so it must be obtained through nutrition. This is achieved by incorporating foods such as dark leafy greens and egg yolks into one's diet or by opting for dietary supplements. Recent findings indicate that the daily intake of lutein often falls short of providing the related health benefits. This confirms the huge potential for lutein fortification in functional foods. The research team have developed two functional food products fortified with lutein to support human nutrition. These food products are a sports isotonic beverage and cupcakes. This study aims to evaluate the effectiveness of lutein-fortified foods as a method to deliver lutein directly into the human body, through a bioavailability study. The study involves measuring lutein levels in the blood at different time points before and after participants eat a single serving of the lutein-fortified isotonic beverage (500 ml) or cupcake (50g).
Who can participate?
Healthy volunteers between 18-65 years of age, who were a non-smoker, non-pregnant, had no allergies i.e., gluten, eggs, dairy, no chronic disease (e.g., diabetes, cardiovascular diseases, Alzheimer’s disease, etc.), and not currently taking medication or supplements that could potentially interfere with lutein absorption.
What does the study involve?
The study spanned over five days, commencing with a 10-hour session on Day 1, held at the NRCI. Each participant was asked to consume one single serving of either the lutein fortified sport isotonic beverage or the lutein fortified cupcake. After consumption, a qualified phlebotomist withdrew blood from each participant at regular intervals throughout the day. Days 2, 3, 4 and 5 entailed one brief daily visit (15-20 minutes) to the NRCI, where a single blood sample was drawn each day. The first blood sample of each day is a fasting blood sample.
What are the possible benefits and risks of participating?
Benefits for participants are a voucher with €250 spendable in retailers. In addition, the participants could know the levels of lutein in their blood, and their overall carotenoid content at tissue level (skin carotenoid measurement).
The consumption of the lutein-enriched foods is expected to be free of side effects, as participants were pre-screened to confirm the absence of any allergies. All food products used in this trial were fully compliant with all EU food safety regulations and standards and were safe to consume.
However, it's important to note that while uncommon, the blood withdrawal procedures might carry a slight risk of side effects, including bruising, pain, bleeding, fainting, and/or dizziness.
Where is the study run from?
When is the study starting and how long is it expected to run for?
February 2024 to March 2024
Who is funding the study?
Cybercolors Ltd
Who is the main contact?
Dr Alfonso Prado-Cabrero, aprado-cabrero@wit.ie
Contact information
Scientific
Carriganore House, SETU West Campus, Carriganore
Waterford
X91K236
Ireland
 ORCID ID |
0000-0001-8268-5362 |
|---|---|
| Phone | +353 (0) 51834191 |
| alfonso.prado-cabrero@setu.ie |
Public, Principal Investigator
Carriganore House, SETU West Campus, Carriganore
Waterford
X91K236
Ireland
| ORCID ID |
0000-0002-5503-7084 |
|---|---|
| Phone | +353 (0) 51834191 |
| john.nolan@setu.ie |
Study information
| Study design | Single-centre interventional randomized single-dose 96-hour bioavailability human trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Laboratory |
| Study type | Screening |
| Participant information sheet | 47348 ProFiLE Study_Participant information leaflet_FINAL.pdf |
| Scientific title | ProFiLE human bioavailability trial: Lutein bioavailability from a lutein-fortified sports beverage and a lutein-fortified cupcake |
| Study acronym | ProFiLE |
| Study objectives | Lutein is a naturally occurring carotenoid and colour pigment that is considered an antioxidant and anti-inflammatory bioactive that protects the retina and contributes to brain health. Lutein is commonly found in dark green leafy vegetables such as spinach and kale, and in fruits such as oranges and papayas. Due to the low consumption of such foods among the general population, lutein is not consumed in adequate amounts to reap its health benefits. Individuals with age-related macular degeneration (AMD) and people aiming to improve their vision and cognition consume lutein through capsules. However, children and many elderly people have swallowing difficulties. Therefore, it is desirable to develop alternative methods to increase lutein intake among the population. Functional foods offer this opportunity, as they include added bioactives among their ingredients. This human bioavailability study aimed to test the capacity of two lutein-fortified foods prepared by our group to increase the levels of lutein in the bloodstream of human participants. |
| Ethics approval(s) |
Approved 27/02/2024, South East Technological University (SETU) Research Ethics Committee (Main Campus Cork Road, Waterford, X91 KOEK, Ireland; +353(0)51302000; Ethics.wd@setu.ie), ref: SETU/REC/23/24/001 |
| Health condition(s) or problem(s) studied | Healthy individuals |
| Intervention | Random allocation sequencing was performed by the study statistician. Participants were randomly allocated to two active intervention groups, and a 5% level of significance was chosen (i.e. 95% confidence level). Participants were randomly allocated into one of the two groups: Group 1 (10 people) consumed 500 mL of a sports beverage that has been fortified with an emulsion of the carotenoid lutein (~10 mg lutein). Group 2 (9 people) consumed one 50-g cupcake that had been fortified with an emulsion of lutein (~10 mg lutein). The study spanned over five days, commencing with a 10-hour session on Day 1. Each participant was asked to consume one single serving of either the lutein fortified sport isotonic beverage or the lutein fortified cupcake. After consumption, a qualified phlebotomist withdrew blood from each participant at regular intervals throughout the day. Days 2, 3, 4 and 5 entailed one brief daily visit (15-20 minutes) to the study centre, where a single blood sample was drawn each day. The first blood sample of each day is a fasting blood sample. |
| Intervention type | Supplement |
| Primary outcome measure | Lutein is measured using high-performance liquid chromatography with diode array detection (HPLC-DAD) at baseline, and 3, 6, 10, 24, 48, 72 and 96 hours after taking the lutein-fortified food |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 27/02/2024 |
| Completion date | 27/03/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 19 |
| Key inclusion criteria | 1. Healthy adults, defined as currently/historically not having a chronic disease, having no history of gastrointestinal diseases that could inhibit lutein absorption, having no current severe illnesses or infections, and having not undergone major surgery within the last 6 months 2. Aged between 18 and 65 years old 3. No food allergies 4. Not taking any medications or dietary supplements that would interfere with lutein absorption |
| Key exclusion criteria | 1. Pregnant or lactating women 2. Participants taking medications or supplements known to impact lutein absorption 3. Individuals with allergies to gluten, eggs, and dairy were excluded from the study as the intervention required participants to ingest lutein-fortified foods containing gluten (flour), eggs, and dairy ingredients (butter) |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 27/03/2024 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Waterford
X91K236
Ireland
Sponsor information
University/education
Cork Road
Waterford
X91KOEK
Ireland
| Phone | +353 (0) 818 121212 |
|---|---|
| info@cybercolors.ie | |
| Website | https://www.setu.ie |
"ROR" |
https://ror.org/03fgx6868 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 15/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study are not expected to be made available (private funding). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 27/05/2025 | No | Yes |
Additional files
Editorial Notes
16/05/2025: Study's existence confirmed by the South East Technological University (SETU) Research Ethics Committee.
