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OpenTrials
Completed

NCT Number: NCT01730898

Lutein Absorption in Healthy Adults

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

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Biofortis Clinical Research

Addison, Illinois, 60101, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study product containing lutein

Other

delivered in capsule form

Primary outcomes

  1. Plasma lutein

    Time frame: baseline and 336 hours

    adjusted area under the curve at specified postprandial timepoint

Secondary outcomes

  1. Plasma carotenoids

    Time frame: 2, 4, 6, 8, 12, 24, 48, and 336 hours

    mean concentrations at specified postprandial timepoints

  2. Plasma lipid concentrations

    Time frame: baseline and 48 hours

    averaged concentrations at specified postprandial timepoints

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 21, 2012
Registry last updated
Jul 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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