Absorption of Carotenoids From VegetablesNCT01006174
Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables
A study testing Soybean Oil, Canola Oil and Butter in people with Absorption of Carotenoids From Vegetables, run by Purdue University at 1 site in United States.
Trial summary
The purpose of this research study is to determine how dietary fats and oils influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine changes in blood carotenoids in response to eating a salad with different fats/oils. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Absorption of Carotenoids From Vegetables
- What is being tested?
- Soybean Oil, Canola Oil and Butter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2010
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range: 18-50 years.
- Body mass index (BMI: weight (kg)/height (m2)) ranging from 20-29 kg/m²
- Weight stable (<4.5 kg change within the last 3 months),
- Constant habitual activity pattern, not to exceed activities of a recreational level over the past 3 months.
- Must be pre-menopausal
- Have clinically normal blood profiles (specifically normal liver and kidney functions and fasting blood glucose of ≤110 mg/dl)
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- Non-smoking
- Non-diabetic
- No current or planned pregnancy
- Not using any hormone-based contraceptive, e.g., pill, patch, injection, implants, etc.
- No current use of medication affecting lipid profile
- No intestinal disorders including lipid malabsorption, lactose intolerance
- No heavy consumption of alcohol (>2 drinks per day)
- No current use of dietary supplements that affect cholesterol, (e.g. Benocol or fiber supplements) or a willingness to discontinue their use during the study.
Who cannot join
- Menopausal
- Diabetic
- Currently pregnant
- Currently using any type of hormone-based contraceptives, (e.g., pill, patch, injection, implants, etc.)
- Use of lipid altering medications
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to determine how dietary fats and oils influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine changes in blood carotenoids in response to eating a salad with different fats/oils.
- Being tested
- Soybean Oil, Canola Oil, Butter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soybean OilOther
Depending on the experimental group assigned, each subject which will be given one of three different amounts of soybean oil that is added to a salad.
Canola OilOther
Depending on the experimental group assigned, each subject which will be given one of three different amounts of canola oil that is added to a salad.
ButterOther
Depending on the experimental group assigned, each subject which will be given one of three different amounts of butter that is added to a salad.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Subjects will be assigned to consume 3 grams soybean oil, 8 grams canola oil, and 20 grams butter that is added to a salad. Receives: Other: Soybean Oil; Other: Canola Oil; Other: Butter |
| B | Experimental | Subjects will be assigned to consume 8 grams soybean oil, 20 grams canola oil, and 3 grams butter that is added to a salad. Receives: Other: Soybean Oil; Other: Canola Oil; Other: Butter |
| C | Experimental | Subjects will be assigned to consume 20 grams soybean oil, 3 grams canola oil, and 8 grams butter that is added to a salad. Receives: Other: Soybean Oil; Other: Canola Oil; Other: Butter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the impact of dietary lipid profiles on intestinal absorption of carotenoids from vegetables.
Measured: 66 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Absorption of Carotenoids From VegetablesStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006174
- Sponsor's protocol ID
- 0707005641
- Status last verified
- Jan 2013
- First submitted
- 30 Oct 2009
- Last updated
- 17 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Lipids as Primary Modulators of Carotenoid Absorption in Vegetables
- ClinicalTrials.gov ID
- NCT01006174
- Acronym / sponsor ID
- 0707005641
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Nov 2009 (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 purpose of this research study is to determine how dietary fats and oils influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The study will examine changes in blood carotenoids in response to eating a salad with different fats/oils.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Other: Soybean Oil, Other: Canola Oil, Other: ButterSubjects will be assigned to consume 3 grams soybean oil, 8 grams canola oil, and 20 grams butter that is added to a salad. |
| B | Experimental | Other: Soybean Oil, Other: Canola Oil, Other: ButterSubjects will be assigned to consume 8 grams soybean oil, 20 grams canola oil, and 3 grams butter that is added to a salad. |
| C | Experimental | Other: Soybean Oil, Other: Canola Oil, Other: ButterSubjects will be assigned to consume 20 grams soybean oil, 3 grams canola oil, and 8 grams butter that is added to a salad. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age range: 18-50 years.
- Body mass index (BMI: weight (kg)/height (m2)) ranging from 20-29 kg/m²
- Weight stable (<4.5 kg change within the last 3 months),
- Constant habitual activity pattern, not to exceed activities of a recreational level over the past 3 months.
- Must be pre-menopausal
Key exclusion criteria (5 listed)
- Menopausal
- Diabetic
- Currently pregnant
- Currently using any type of hormone-based contraceptives, (e.g., pill, patch, injection, implants, etc.)
- Use of lipid altering medications
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 OilDepending on the experimental group assigned, each subject which will be given one of three different amounts of soybean oil that is added to a salad. | Other | A, B, C |
| Canola OilDepending on the experimental group assigned, each subject which will be given one of three different amounts of canola oil that is added to a salad. | Other | A, B, C |
| ButterDepending on the experimental group assigned, each subject which will be given one of three different amounts of butter that is added to a salad. | Other | A, B, C |
Primary outcome
Evaluating the impact of dietary lipid profiles on intestinal absorption of carotenoids from vegetables.
Time frame: 66 days
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 17 Jan 2013.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soybean Oil, Canola Oil and Butter in people with Absorption of Carotenoids From Vegetables, run by Purdue University 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 14 inclusion and 5 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 17 Jan 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.
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?
Evaluating the impact of dietary lipid profiles on intestinal absorption of carotenoids from vegetables. (time frame: 66 days). 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 17 Jan 2013.