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ProFiLE human bioavailability trial: Lutein bioavailability from a lutein-fortified sports beverage and a lutein-fortified cupcake

ProFiLE human bioavailability trial: Lutein bioavailability from a lutein-fortified sports beverage and a lutein-fortified cupcake

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13108633
Enrollment
20
Registered
2025-08-11
Start date
2024-03-01
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy individuals Other

Interventions

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% confid

Sponsors

South East Technological University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
There are no secondary outcome measures

Countries

Ireland

Contacts

Public ContactJohn Nolan
john.nolan@setu.ie+353 (0) 51834191

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026