Lutein Absorption in Healthy Adults

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Other: Study product containing lutein

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control capsule; 2 capsules	Other: Study product containing lutein; delivered in capsule form
Experimental: Experimental capsule; 2 capsules	Other: Study product containing lutein; delivered in capsule form

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Jennifer Williams, Abbott Nutrition

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: November 16, 2012
• First Posted (Estimate): November 21, 2012

Study Record Updates

• Last Update Posted (Estimate): July 4, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: BL14