Lutein Absorption in Healthy Adults

Abbott

Status and phase

Completed

Phase 3

Conditions

Healthy Subjects

Treatments

Other: Study product containing lutein

Study type

Interventional

Funder types

Industry

Identifiers

BL14

Details and patient eligibility

About

This study will evaluate the absorption of lutein when consumed in different oil blends.

Enrollment

24 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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