Lutein Absorption in Healthy Adults

Study Overview
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Brief Summary
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This study will evaluate the absorption of lutein when consumed in different oil blends.

Official Title
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Lutein Absorption in Healthy Adults

Conditions
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Healthy Subjects

Intervention / Treatment
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* Other: Study product containing lutein
* Other: Study product containing lutein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following inclusion criteria: BMI ≥ 18 and ≤ 25 kg/m2 Between 18 and 45 years of age, inclusive Male or a non-pregnant, non-lactating female, nulliparous or at least 6 weeks postpartum prior to screening visit. A urine pregnancy test is required for all female subjects unless she is not of childbearing potential. If female is of childbearing potential, is practicing one of the following methods of birth control (and will continue through the duration of the study): Condoms, sponge, diaphragm or intrauterine device; Oral or parenteral contraceptives for 3 months prior to screening visit; Vasectomized partner; Total abstinence from sexual intercourse. If on a chronic medication, subject has been on constant dosage for at least two months prior to screening visit Exclusion Criteria: Subjects will be excluded from the study if they meet any of the following criteria: Current smoker Current chronic disease, including malabsorption or gastrointestinal disorders; hyperlipidemia; anemia; hemophilia; excessive bleeding; cystic fibrosis; kidney disease requiring dialysis; diabetes; active malignancy; wasting condition Current chronic contagious, infectious disease, such as active tuberculosis, Hepatitis B or C,or HIV Vegetarian, or has very selective food habits/dieting Average intake of alcoholic beverages greater than 2 drinks per day Medication or dietary supplement use to lower plasma lipids or affect lipid absorption or transport, including antibiotics Supplement use that contains carotenoids (multi-vitamin as an example) Known allergy or intolerance to any ingredient found in the study products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control capsule<br>2 capsules | Other: Study product containing lutein<br>* delivered in capsule form<br>|
| Experimental: Experimental capsule<br>2 capsules | Other: Study product containing lutein<br>* delivered in capsule form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma lutein | adjusted area under the curve at specified postprandial timepoint | baseline and 336 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma carotenoids | mean concentrations at specified postprandial timepoints | 2, 4, 6, 8, 12, 24, 48, and 336 hours | 
| Plasma lipid concentrations | averaged concentrations at specified postprandial timepoints | baseline and 48 hours |