Macula Lutea Opacity Clinical Trial
— FSLA20Official title:
Lutein Absorption Consumed as Supplement, Blended Food, or Wholefood Over 24-hours.
| NCT number | NCT04786392 |
| Other study ID # | 2020002809 |
| Secondary ID | |
| Status | Withdrawn |
| Phase | Phase 1 |
| First received | |
| Last updated | |
| Start date | June 2021 |
| Est. completion date | June 2021 |
| Verified date | January 2021 |
| Source | The University of Queensland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The aim of this study is to investigate in healthy adults, 18-40 years of age, how the absorption of 5 mg of L differs between consumption as a supplement, blended foods, and whole food equivalent of blended foods.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | June 2021 |
| Est. primary completion date | June 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 40 Years |
| Eligibility | Inclusion Criteria: - Male and females 18 to 40 years. - Generally healthy. - No participant reported history of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled. - Non-smoker. - English language proficiency Exclusion Criteria: - Participant reported diagnosis of serious ocular conditions (e.g. cataracts, glaucoma, diabetic retinopathy, retinitis pigmentosa, Stagardt's disease) - Participant reported diagnosis, or current treatment of age-related macular degeneration. - Participant reported diagnosis of epilepsy. - Participant aversion, intolerance or allergy to study foods to be consumed (spinach, ginger, lemon, apple, flaxseeds) - A female currently pregnant or trying to fall pregnant. - Current or past smoker (within last 12 months). - Under 18 or over 40 years of age. - Currently taking a lutein supplement or consuming large amounts of foods containing lutein on a regular basis (>3 days per week). |
| Country | Name | City | State |
|---|---|---|---|
| Australia | School of Human Movement and Nutrition Sciences, The University of Queensland | Saint Lucia | Queensland |
| Lead Sponsor | Collaborator |
|---|---|
| The University of Queensland |
Australia,
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Bernstein PS, Li B, Vachali PP, Gorusupudi A, Shyam R, Henriksen BS, Nolan JM. Lutein, zeaxanthin, and meso-zeaxanthin: The basic and clinical science underlying carotenoid-based nutritional interventions against ocular disease. Prog Retin Eye Res. 2016 Jan;50:34-66. doi: 10.1016/j.preteyeres.2015.10.003. Epub 2015 Nov 2. Review. — View Citation
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* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Plasma lutein concentration | Area under the curve of plasma lutein concentrations between 0 and 24 hours post lutein consumption. | Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours) | |
| Secondary | Plasma lutein maximum concentration | Maximum concentration of plasma lutein reached over 24 hours of measurement, and time point of maximum concentration. | Study visit 1 (24 hours), Study visit 2 (24 hours), study visit 3 (24 hours) | |
| Secondary | Macular pigment optical density | Machine: measured by the Macular Pigment Screener II (Elektron Eye Technology). The non-invasive test uses heterochromatic flicker photometry. One measure completed at each study visit (3 study visits total). | Study visit day 1, day 8, day 15 | |
| Secondary | Daily dietary lutein and zeaxanthin intake | Daily dietary intake of lutein and zeaxanthin (mg/day) as measured by a food frequency questionnaire. | Study visit day 1 | |
| Secondary | Daily dietary lutein and zeaxanthin intake | Daily dietary intake of lutein and zeaxanthin (mg/day) as measured by a food frequency questionnaire. | Study visit day 1, day 8, day 15 |