Healthy Subjects
Conditions
Brief summary
This study will evaluate the absorption of lutein when consumed in different oil blends.
Interventions
OTHERStudy product containing lutein
delivered in capsule form
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma lutein | baseline and 336 hours | adjusted area under the curve at specified postprandial timepoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma carotenoids | 2, 4, 6, 8, 12, 24, 48, and 336 hours | mean concentrations at specified postprandial timepoints |
| Plasma lipid concentrations | baseline and 48 hours | averaged concentrations at specified postprandial timepoints |
Countries
United States
Outcome results
None listed