Lutein Absorption in Healthy Adults

NCT01730898 | Completed Phase 3

• 1 other identifier: BL14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Plasma lutein

  adjusted area under the curve at specified postprandial timepoint

  baseline and 336 hours

Secondary Outcomes (2)

• Plasma carotenoids

  2, 4, 6, 8, 12, 24, 48, and 336 hours

• Plasma lipid concentrations

  baseline and 48 hours

Study Arms (2)

Control capsule

ACTIVE COMPARATOR

2 capsules

Other: Study product containing lutein

Experimental capsule

EXPERIMENTAL

2 capsules

Other: Study product containing lutein

Interventions

Study product containing lutein OTHER

delivered in capsule form

Control capsule

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Nutrition: lead

Study Sites (1)

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Location

Study Officials

• Jennifer Williams

  Abbott Nutrition

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 4, 2013

Record last verified: 2013-07

Locations

US (1)