The efficacy of different nutritional formulas of lutein, zeaxanthin, and meso-zeaxanthin and their impact on the human body

The impact of formulation on lutein, zeaxanthin, and meso-zeaxanthin bioavailability: a randomized double-blind placebo-controlled study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN18206561

Enrollment

Registered

2020-07-30

Start date

2017-09-01

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

The impact of formulation on lutein, zeaxanthin, and meso-zeaxanthin bioavailability in a healthy Irish adult sample Nutritional, Metabolic, Endocrine

Interventions

Participants were blocked randomized, with equal probability and separately for men and women, to one of five active intervention groups, or to a placebo group. Block randomization was performed using

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy adults 2. Age group between 18 and 65 years

Exclusion criteria

Exclusion criteria: 1. A medical diagnosis of a critical or acute medical condition 2. Intake of nutritional supplements containing lutein, zeaxanthin, meso-zeaxanthin or omega-3 fatty acids

Design outcomes

Primary

Measure	Time frame
Lutein, zeaxanthin, and meso-zeaxanthin bioavailability measured in serum, macular pigment, and skin using high-performance liquid chromatography (HPLC), the Spectralis investigational macular pigment optical density (MPOD) module, and the Nu Skin Pharmanex S3 scanner, respectively, at baseline and 6 months	—

Secondary

Measure	Time frame
1. Serum lipid concentrations measured from a blood sample using mass spectrometry at baseline and 6 months 2. DHA and EPA measured from a blood sample using gas chromatography at baseline and 6 months 3. Visual function measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) logarithm of the minimum angle of resolution (LogMAR) chart (Test Chart 2000 PROTM) for Best-corrected visual acuity (BCVA); the LogMAR EDTRS (Test Chart 2000 PROTM) for Letter Contrast Sensitivity (CS); the “Advanced Vision and Optometric Tests” (AVOT) for visual acuity, contrast sensitivity, cone and rod vision; at baseline and 6 months 4. Cognitive function measured using tests of attention, memory, executive function and decision making from the Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, UK) at baseline and 6 months 5. Medical information obtained through a questionnaire and physical examination at baseline and 6 months	—

Measure

Time frame

1. Serum lipid concentrations measured from a blood sample using mass spectrometry at baseline and 6 months 2. DHA and EPA measured from a blood sample using gas chromatography at baseline and 6 months 3. Visual function measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) logarithm of the minimum angle of resolution (LogMAR) chart (Test Chart 2000 PROTM) for Best-corrected visual acuity (BCVA); the LogMAR EDTRS (Test Chart 2000 PROTM) for Letter Contrast Sensitivity (CS); the “Advanced Vision and Optometric Tests” (AVOT) for visual acuity, contrast sensitivity, cone and rod vision; at baseline and 6 months 4. Cognitive function measured using tests of attention, memory, executive function and decision making from the Cambridge Neuropsychological Test Automated Battery (CANTAB, Cambridge Cognition, UK) at baseline and 6 months 5. Medical information obtained through a questionnaire and physical examination at baseline and 6 months

—

Countries

Ireland

Contacts

Public ContactMarina Green

mgreen@wit.ie+353 (0)51 306261

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026