Lutein Absorption in Healthy Adults

NCT ID: NCT01730898

Last Updated: 2013-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-03-31

Brief Summary

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

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Control capsule

2 capsules

Group Type: ACTIVE_COMPARATOR

Study product containing lutein

Intervention Type: OTHER

delivered in capsule form

Experimental capsule

2 capsules

Group Type: EXPERIMENTAL

Study product containing lutein

Intervention Type: OTHER

delivered in capsule form

Interventions

Study product containing lutein

delivered in capsule form

Intervention Type: OTHER

Study product containing lutein

delivered in capsule form

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Nutrition

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Williams

Role: STUDY_CHAIR

Abbott Nutrition

Locations

Biofortis Clinical Research

Addison, Illinois, United States

Countries

United States

Other Identifiers

BL14

Identifier Type: -

Identifier Source: org_study_id