Lutein Absorption in Healthy Adults

Phase 3

Completed

• Conditions: Healthy Subjects
• Interventions: Other: Study product containing lutein

• Registration Number: NCT01730898
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-21
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-02
• Last Update Posted: 2013-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control capsule	Study product containing lutein	2 capsules
Experimental capsule	Study product containing lutein	2 capsules

Primary Outcome Measures

Name	Time	Method
Plasma lutein	baseline and 336 hours	adjusted area under the curve at specified postprandial timepoint

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Biofortis Clinical Research; 🇺🇸 Addison, Illinois, United States