HealthyNCT01432210
Provitamin A Absorption and Conversion With Avocados
A study testing Post-prandial Feeding Study in people with Healthy, run by Ohio State University at 1 site in United States.
Trial summary
Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and vegetables is not "active" and must be converted to the active form in the human body. However, information on the ability of humans to absorb and convert vitamin A to the active form is still lacking. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Post-prandial Feeding Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Mar 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Total cholesterol (140 to 200 mg/dL)
- BMI 17 to 30
- Age 18-70 years
Who cannot join
- Lactating, pregnant, or plan to be pregnant during study
- Tobacco use (cigarettes or chewing tobacco)
- Metabolic disease
- Malabsorption disorders
- History of cancer, esophageal, gastric, or intestinal ulcers
- History of liver or kidney insufficiency or failure
Show all 11Show fewer
- Allergies to tomatoes or tomato products
- Allergies to carrots
- Allergies to avocados
- Obesity (BMI>30)
- Hypercholesterolemia (total cholesterol> 200mg/dL)
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Clinical Research Center
Columbus, Ohio, 43210
About this study
Official title: Enhancing Human Intestinal Absorption of Carotenoids and Bioconversion of Carotene to Vitamin A in the Presence of Hass Avocados
Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and vegetables is not "active" and must be converted to the active form in the human body. However, information on the ability of humans to absorb and convert vitamin A to the active form is still lacking. In this study, the investigators will observe the absorption and conversion of vitamin A from orange tomato sauce and/or carrots after a meal with fat (from avocado fruit) and a meal without fat. The investigators will also test whether eating these foods might protect the blood against damage that could lead to heart disease.
Read the detailed description
The primary objective of this study will be to demonstrate that adding avocados to a carotene rich meal will promote the absorption of provitamin A carotenoids and enhance the delivery of greater quantities of vitamin A. This objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites after subjects consume a meal with or without avocado in combination with a serving of tomato sauce (containing nutritionally relevant amounts of beta-carotene) or carrots.
The secondary objective of this study will be to determine if higher levels of carotenoids and other antioxidants transported in the bloodstream will have a protective role in promoting cardiovascular health. This objective will be accomplished by testing the oxidation capacity of lipoprotein fractions before and after meal supplementation.
- Conditions
- Healthy
- Being tested
- Post-prandial Feeding Study
- Keywords
- post-prandial absorption, provitamin A carotenoids, vitamin A, avocado, tomato, carrot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-prandial Feeding StudyOther
| Study group | Role | What they receive |
|---|---|---|
| Tomato Meal | Other | A tomato meal will be fed with and without avocado. Receives: Other: Post-prandial Feeding Study |
| Carrot Meal | Other | A carrot meal will be fed with and without avocado. Receives: Other: Post-prandial Feeding Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial levels of provitamin A and vitamin A
The absorption of and conversion of provitamin A carotenoids into vitamin A will be measured after the consumption of a carotenoid-rich meal. The meal will be served both with and without avocado as a source of lipid.
Measured: Nine post-prandial blood samples will be taken over twelve hours
Secondary outcomes (1)
post-prandial antioxidant status of blood
The ability of a carotenoid-rich meal to reduce the susceptibility of blood lipoproteins to oxidative stress will be tested. A modified trolox equivalent antioxidant capacity (TEAC) assay will be used.
Measured: comparing baseline vs. 5 hour status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJan 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Hass Avocado Board
- Responsible party
- Principal investigator, Jessica Cooperstone, Ohio State University
- Investigators
- Steven J Schwartz, Ph.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432210
- Sponsor's protocol ID
- 2011H0159
- Other IDs
- 60030575
- Status last verified
- Sep 2016
- First submitted
- 4 Sep 2011
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cooperstone JL, Goetz HJ, Riedl KM, Harrison EH, Schwartz SJ, Kopec RE. Relative contribution of alpha-carotene to postprandial vitamin A concentrations in healthy humans after carrot consumption. Am J Clin Nutr. 2017 Jul;106(1):59-66. doi: 10.3945/ajcn.116.150821. Epub 2017 May 17.
PubMed 28515067Kopec RE, Cooperstone JL, Schweiggert RM, Young GS, Harrison EH, Francis DM, Clinton SK, Schwartz SJ. Avocado consumption enhances human postprandial provitamin A absorption and conversion from a novel high-beta-carotene tomato sauce and from carrots. J Nutr. 2014 Aug;144(8):1158-66. doi: 10.3945/jn.113.187674. Epub 2014 Jun 4.
PubMed 24899156
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Human Intestinal Absorption of Carotenoids and Bioconversion of Carotene to Vitamin A in the Presence of Hass Avocados
- ClinicalTrials.gov ID
- NCT01432210
- Acronym / sponsor ID
- 2011H0159
- Conditions
- Healthy
- Keywords
- post-prandial absorption, provitamin A carotenoids, vitamin A, avocado, tomato, carrot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Hass Avocado Board
- Study start
- Sep 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 12 Sep 2011 (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.
Vitamin A is necessary in the human diet. The form of vitamin A found in fruits and vegetables is not "active" and must be converted to the active form in the human body. However, information on the ability of humans to absorb and convert vitamin A to the active form is still lacking. In this study, the investigators will observe the absorption and conversion of vitamin A from orange tomato sauce and/or carrots after a meal with fat (from avocado fruit) and a meal without fat. The investigators will also test whether eating these foods might protect the blood against damage that could lead to heart disease.
Detailed description
The primary objective of this study will be to demonstrate that adding avocados to a carotene rich meal will promote the absorption of provitamin A carotenoids and enhance the delivery of greater quantities of vitamin A. This objective will be accomplished by quantitation of the immediate post-prandial plasma concentrations of parent carotenoids and vitamin A metabolites after subjects consume a meal with or without avocado in combination with a serving of tomato sauce (containing nutritionally relevant amounts of beta-carotene) or carrots.
The secondary objective of this study will be to determine if higher levels of carotenoids and other antioxidants transported in the bloodstream will have a protective role in promoting cardiovascular health. This objective will be accomplished by testing the oxidation capacity of lipoprotein fractions before and after meal supplementation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tomato Meal | Other | Other: Post-prandial Feeding StudyA tomato meal will be fed with and without avocado. |
| Carrot Meal | Other | Other: Post-prandial Feeding StudyA carrot meal will be fed with and without avocado. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Total cholesterol (140 to 200 mg/dL)
- BMI 17 to 30
- Age 18-70 years
Key exclusion criteria (11 listed)
- Lactating, pregnant, or plan to be pregnant during study
- Tobacco use (cigarettes or chewing tobacco)
- Metabolic disease
- Malabsorption disorders
- History of cancer, esophageal, gastric, or intestinal ulcers
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 |
|---|---|---|
| Post-prandial Feeding Study | Other | Carrot Meal, Tomato Meal |
Primary outcome
Post-prandial levels of provitamin A and vitamin A
Time frame: Nine post-prandial blood samples will be taken over twelve hours
The absorption of and conversion of provitamin A carotenoids into vitamin A will be measured after the consumption of a carotenoid-rich meal. The meal will be served both with and without avocado as a source of lipid.
1 secondary outcome
post-prandial antioxidant status of blood
Time frame: comparing baseline vs. 5 hour status
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 30 Sep 2016.
- Derived from this study: PubMed 28515067Cooperstone JL, Goetz HJ, Riedl KM, Harrison EH, Schwartz SJ, Kopec RE. Relative contribution of alpha-carotene to postprandial vitamin A concentrations in healthy humans after carrot consumption. Am J Clin Nutr. 2017 Jul;106(1):59-66. doi: 10.3945/ajcn.116.150821. Epub 2017 May 17.
- Derived from this study: PubMed 24899156Kopec RE, Cooperstone JL, Schweiggert RM, Young GS, Harrison EH, Francis DM, Clinton SK, Schwartz SJ. Avocado consumption enhances human postprandial provitamin A absorption and conversion from a novel high-beta-carotene tomato sauce and from carrots. J Nutr. 2014 Aug;144(8):1158-66. doi: 10.3945/jn.113.187674. Epub 2014 Jun 4.
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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.
Steven J Schwartz, Ph.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-prandial Feeding Study in people with Healthy, run by Ohio State 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 3 inclusion and 11 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 30 Sep 2016. 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?
Post-prandial levels of provitamin A and vitamin A (time frame: Nine post-prandial blood samples will be taken over twelve hours). 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 NCT01432210, which also lists 2 linked publications.
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 30 Sep 2016.