Biological AvailabilityNCT02867488
Dose-response Effects of Soybean Oil in Salad Dressing on Carotenoid/Fat-soluble Vitamin Bioavailability in Salad Vegetables
A study testing Soybean oil in salad dressing in people with Biological Availability, run by Iowa State University.
Trial summary
The objectives will be to evaluate the dose-response between the amount of soybean oil in salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and beta-carotene. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Biological Availability
- What is being tested?
- Soybean oil in salad dressing
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jun 2016
- Phase
- Interventional
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- General good health as determined by interview, blood biochemistry profile, complete blood count, and plasma lipid and lipoprotein profile
Who cannot join
- Cigarette smoking, frequent alcohol consumption
- Use of vitamin/mineral supplements
- Lactose intolerance
- Known food allergies
- Body mass index (BMI) 30 or higher
- Eating disorder or restrained eating
Show all 10Show fewer
- Vegetarianism
- Hyperlipidemia
- Current or planned pregnancy
- Use of hormonal contraceptives (affects chylomicron clearance); use of plant sterols or medications known to affect lipid metabolism
About this study
The objectives will be to evaluate the dose-response between the amount of soybean oil in salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and beta-carotene.
- Conditions
- Biological Availability
- Being tested
- Soybean oil in salad dressing
- Keywords
- carotenoids, phylloquinone, tocopherols, vitamin A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soybean oil in salad dressingOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve for carotenoids, phylloquinone, tocopherols, and retinyl palmitate in the plasma chylomicron fraction
Measured: 0-9.5 hours postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biological AvailabilityStudies 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 N/A
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy S. White, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867488
- Sponsor's protocol ID
- 08-549
- Status last verified
- Aug 2016
- First submitted
- 11 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
Publications
White WS, Zhou Y, Crane A, Dixon P, Quadt F, Flendrig LM. Modeling the dose effects of soybean oil in salad dressing on carotenoid and fat-soluble vitamin bioavailability in salad vegetables. Am J Clin Nutr. 2017 Oct;106(4):1041-1051. doi: 10.3945/ajcn.117.153635. Epub 2017 Aug 16.
PubMed 28814399
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-response Effects of Soybean Oil in Salad Dressing on Carotenoid/Fat-soluble Vitamin Bioavailability in Salad Vegetables
- ClinicalTrials.gov ID
- NCT02867488
- Acronym / sponsor ID
- 08-549
- Conditions
- Biological Availability
- Keywords
- carotenoids, phylloquinone, tocopherols, vitamin A
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 16 Aug 2016 (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.
The objectives will be to evaluate the dose-response between the amount of soybean oil in salad dressing and the absorption of: 1) carotenoids, phylloquinone, and tocopherols in salad vegetables; 2) retinyl palmitate formed from the provitamin A carotenoids, alpha- and beta-carotene.
Study design
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- General good health as determined by interview, blood biochemistry profile, complete blood count, and plasma lipid and lipoprotein profile
Key exclusion criteria (10 listed)
- Cigarette smoking, frequent alcohol consumption
- Use of vitamin/mineral supplements
- Lactose intolerance
- Known food allergies
- Body mass index (BMI) 30 or higher
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 |
|---|---|---|
| Soybean oil in salad dressing | Other | – |
Primary outcome
Area under the curve for carotenoids, phylloquinone, tocopherols, and retinyl palmitate in the plasma chylomicron fraction
Time frame: 0-9.5 hours postprandially
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 18 Aug 2016.
- Derived from this study: PubMed 28814399White WS, Zhou Y, Crane A, Dixon P, Quadt F, Flendrig LM. Modeling the dose effects of soybean oil in salad dressing on carotenoid and fat-soluble vitamin bioavailability in salad vegetables. Am J Clin Nutr. 2017 Oct;106(4):1041-1051. doi: 10.3945/ajcn.117.153635. Epub 2017 Aug 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Soybean oil in salad dressing in people with Biological Availability, run by Iowa State University.
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 1 inclusion and 10 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 18 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Area under the curve for carotenoids, phylloquinone, tocopherols, and retinyl palmitate in the plasma chylomicron fraction (time frame: 0-9.5 hours postprandially). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02867488, which also lists 1 linked publication.
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 18 Aug 2016.