Lutein Absorption in Healthy Adults

Healthy Subjects Clinical Trial

Official title:

Lutein Absorption in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730898
• Other study ID #: BL14
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2012
• Last updated: July 2, 2013
• Start date: November 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2013
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Other:
• Study product containing lutein
delivered in capsule form
• Study product containing lutein
delivered in capsule form

Locations

Country	Name	City	State
United States	Biofortis Clinical Research	Addison	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma lutein	adjusted area under the curve at specified postprandial timepoint	baseline and 336 hours	No
Secondary	Plasma carotenoids	mean concentrations at specified postprandial timepoints	2, 4, 6, 8, 12, 24, 48, and 336 hours	No
Secondary	Plasma lipid concentrations	averaged concentrations at specified postprandial timepoints	baseline and 48 hours	No