Lutein Absorption in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01730898
First received: November 16, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Other: Study product containing lutein
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Lutein Absorption in Healthy Adults

Resource links provided by NLM:


Further study details as provided by Abbott Nutrition:

Primary Outcome Measures:
  • Plasma lutein [ Time Frame: baseline and 336 hours ] [ Designated as safety issue: No ]
    adjusted area under the curve at specified postprandial timepoint


Secondary Outcome Measures:
  • Plasma carotenoids [ Time Frame: 2, 4, 6, 8, 12, 24, 48, and 336 hours ] [ Designated as safety issue: No ]
    mean concentrations at specified postprandial timepoints

  • Plasma lipid concentrations [ Time Frame: baseline and 48 hours ] [ Designated as safety issue: No ]
    averaged concentrations at specified postprandial timepoints


Enrollment: 24
Study Start Date: November 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730898

Locations
United States, Illinois
Biofortis Clinical Research
Addison, Illinois, United States, 60101
Sponsors and Collaborators
Abbott Nutrition
Investigators
Study Chair: Jennifer Williams Abbott Nutrition
  More Information

No publications provided

Responsible Party: Abbott Nutrition
ClinicalTrials.gov Identifier: NCT01730898     History of Changes
Other Study ID Numbers: BL14
Study First Received: November 16, 2012
Last Updated: July 2, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 01, 2014