CarotenoidS26NCT01856816
Effect of Meal Patterning on Carotenoid Absorption From Vegetables
A study testing Meal Pattern Treatment A, Meal Pattern Treatment B and Meal Pattern Treatment C in people with Carotenoid and Bioavailability, run by Purdue University.
Trial summary
The purpose of this research study is to determine how different meal patterns influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is that carotenoid absorption will be lower when daily vegetables are consumed in one meal compared two smaller meals throughout the day. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Carotenoid, Bioavailability, Dietary Modification
- What is being tested?
- Meal Pattern Treatment A, Meal Pattern Treatment B and Meal Pattern Treatment C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Aug 2011
- 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
- Men only
- 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
- Have clinically normal blood profiles (specifically normal liver and kidney functions and fasting blood glucose of ≤110 mg/dl)
- Non-smoking
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- Non-diabetic
- 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
- Diabetic
- Use of lipid altering medications
About this study
The purpose of this research study is to determine how different meal patterns influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is that carotenoid absorption will be lower when daily vegetables are consumed in one meal compared two smaller meals throughout the day.
- Conditions
- Carotenoid, Bioavailability, Dietary Modification
- Being tested
- Meal Pattern Treatment A, Meal Pattern Treatment B, Meal Pattern Treatment C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal Pattern Treatment AOther
In treatment A, subjects consumed 100% of salad vegetables and canola oil in the first meal and 0% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.
Meal Pattern Treatment BOther
In treatment B, subjects consumed 50% of salad vegetables and canola oil in the first meal and 50% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.
Meal Pattern Treatment COther
In treatment C, subjects consumed 75% of vegetables and oil in the first meal and 25% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals.
| Study group | Role | What they receive |
|---|---|---|
| Meal Pattern Treatment A | Experimental | A large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group A. Receives: Other: Meal Pattern Treatment A |
| Meal Pattern Treatment B | Experimental | A large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group B. Receives: Other: Meal Pattern Treatment B |
| Treatment Group C | Other | A large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group C. Receives: Other: Meal Pattern Treatment C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration (AUC) vs time curve for carotenoids in the triglyceride-rich lipoprotein (TRL) fraction of plasma.
Measured: 0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarotenoidStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wayne Campbell, Purdue University
- Investigators
- Mario Ferruzzi, PhD, Principal investigator, Purdue UniversityWayne Campbell, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856816
- Sponsor's protocol ID
- 1102010527
- Acronym
- S26
- Status last verified
- May 2013
- First submitted
- 15 May 2013
- Last updated
- 17 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Meal Patterning on Carotenoid Absorption From Vegetables
- ClinicalTrials.gov ID
- NCT01856816
- Acronym / sponsor ID
- S26 / 1102010527
- Conditions
- Carotenoid, Bioavailability, Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 17 May 2013 (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 different meal patterns influence the absorption of beneficial plant pigments (carotenoids) from vegetables. The hypothesis is that carotenoid absorption will be lower when daily vegetables are consumed in one meal compared two smaller meals throughout the day.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Meal Pattern Treatment A | Experimental | Other: Meal Pattern Treatment AA large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group A. |
| Meal Pattern Treatment B | Experimental | Other: Meal Pattern Treatment BA large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group B. |
| Treatment Group C | Other | Other: Meal Pattern Treatment CA large vegetable salad (262g) and with a moderate amount of canola oil (8g) was consumed over a two meal period as designated by treatment group C. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 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
- Have clinically normal blood profiles (specifically normal liver and kidney functions and fasting blood glucose of ≤110 mg/dl)
Key exclusion criteria (2 listed)
- Diabetic
- 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 |
|---|---|---|
| Meal Pattern Treatment AIn treatment A, subjects consumed 100% of salad vegetables and canola oil in the first meal and 0% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals. | Other | Meal Pattern Treatment A |
| Meal Pattern Treatment BIn treatment B, subjects consumed 50% of salad vegetables and canola oil in the first meal and 50% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals. | Other | Meal Pattern Treatment B |
| Meal Pattern Treatment CIn treatment C, subjects consumed 75% of vegetables and oil in the first meal and 25% in the second. Additional protein-rich "chef's salad" ingredients were distributed equally between meals. | Other | Treatment Group C |
Primary outcome
Area under the concentration (AUC) vs time curve for carotenoids in the triglyceride-rich lipoprotein (TRL) fraction of plasma.
Time frame: 0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 hours post dose
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 May 2013.
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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.
Mario Ferruzzi, PhD principal investigator
Purdue University
Wayne Campbell, PhD principal investigator
Purdue University
Questions about this trial
What is this clinical trial studying?
A study testing Meal Pattern Treatment A, Meal Pattern Treatment B and Meal Pattern Treatment C in people with Carotenoid and Bioavailability, run by Purdue 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 11 inclusion and 2 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 May 2013. 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 concentration (AUC) vs time curve for carotenoids in the triglyceride-rich lipoprotein (TRL) fraction of plasma. (time frame: 0, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12 hours post dose). 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 May 2013.