Healthy SubjectsPhase 3NCT01730898
Lutein Absorption in Healthy Adults
A Phase 3 study testing Study product containing lutein in people with Healthy Subjects, run by Abbott Nutrition at 1 site in United States.
Trial summary
This study will evaluate the absorption of lutein when consumed in different oil blends. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Study product containing lutein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
This study will evaluate the absorption of lutein when consumed in different oil blends.
- Conditions
- Healthy Subjects
- Being tested
- Study product containing lutein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study product containing luteinOther
delivered in capsule form
Study product containing luteinOther
delivered in capsule form
| Study group | Role | What they receive |
|---|---|---|
| Control capsule | Active comparator | 2 capsules Receives: Other: Study product containing lutein |
| Experimental capsule | Experimental | 2 capsules Receives: Other: Study product containing lutein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma lutein
adjusted area under the curve at specified postprandial timepoint
Measured: baseline and 336 hours
Secondary outcomes (2)
Plasma carotenoids
mean concentrations at specified postprandial timepoints
Measured: 2, 4, 6, 8, 12, 24, 48, and 336 hours
Plasma lipid concentrations
averaged concentrations at specified postprandial timepoints
Measured: baseline and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Williams, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730898
- Sponsor's protocol ID
- BL14
- Status last verified
- Jul 2013
- First submitted
- 16 Nov 2012
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lutein Absorption in Healthy Adults
- ClinicalTrials.gov ID
- NCT01730898
- Acronym / sponsor ID
- BL14
- Conditions
- Healthy Subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the absorption of lutein when consumed in different oil blends.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control capsule | Active comparator | Other: Study product containing lutein2 capsules |
| Experimental capsule | Experimental | Other: Study product containing lutein2 capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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):
- If on a chronic medication, subject has been on constant dosage for at least two months prior to screening visit
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study product containing luteindelivered in capsule form | Other | Control capsule |
| Study product containing luteindelivered in capsule form | Other | Experimental capsule |
Primary outcome
Plasma lutein
Time frame: baseline and 336 hours
adjusted area under the curve at specified postprandial timepoint
2 secondary outcomes
Plasma carotenoids
Time frame: 2, 4, 6, 8, 12, 24, 48, and 336 hours
Plasma lipid concentrations
Time frame: baseline and 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
Related trials for Healthy Subjects
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Williams study chair
Abbott Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Study product containing lutein in people with Healthy Subjects, run by Abbott Nutrition at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma lutein (time frame: baseline and 336 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2013.