HealthyNCT00680355
Bioavailability of Golden Rice Carotenoids in Humans
A study testing golden rice, corn oil 0g and corn oil 10g in people with Healthy, run by Tufts University at 1 site in United States.
Trial summary
This investigation protocol uses an isotope reference method to evaluate bioavailability of ß-C in rice and its bioconversion to vitamin A. A well-nourished population will be fed hydroponically grown Golden Rice containing ~ 1 mg of β-carotene at day 8 after a reference dose of vitamin A at day 1. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- golden rice, corn oil 0g and corn oil 10g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Aug 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy health
Who cannot join
- GI track problems
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA Human Nutrition Research Center on Aging at Tufts Uni
Boston, Massachusetts, 02111
About this study
This investigation protocol uses an isotope reference method to evaluate bioavailability of ß-C in rice and its bioconversion to vitamin A.
A well-nourished population will be fed hydroponically grown Golden Rice containing ~ 1 mg of β-carotene at day 8 after a reference dose of vitamin A at day 1. The blood samples will be collected up to 33 days after the doses. The absorption kinetics will be determined by tracking both vitamin A and β-carotene in human serum. Blood responses to Golden Rice β-carotene will be determined and evaluated. The vitamin A value of Golden Rice can thus be quantitatively determined.
Read the detailed description
Recently, scientists have genetically engineered "golden rice" that contains 1.6 ug ß-carotene in a gram of dry rice (12). Since the vitamin A equivalency varies from 2 ug (oil dose) to 27 ug (vegetable) carotene to 1 retinol equivalent and the equivalency is matrix dependent, it is necessary to know what the vitamin A equivalency of golden rice beta-carotene is. The determination of the absorption and conversion of golden rice beta-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.
To evaluate the absorption and intestinal conversion of rice beta-carotene after an acute dose of golden rice, an intrinsically labeled Golden Rice with a labeled reference dose of vitamin A are used. We propose to conduct a pilot study on the US adults with normal vitamin A status (n = 15).
The specific aims of this pilot study are:
- To determine ß-carotene response kinetics following a meal of golden rice with 0, 5, or 10 g fat (butter);
- To determine retinol kinetics from the golden rice and from the labeled vitamin A dose;
- To determine vitamin A value of golden rice ß-carotene in adults with normal vitamin A status. The determination of the absorption and conversion of golden rice ß-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.
- Conditions
- Healthy
- Being tested
- golden rice, corn oil 0g, corn oil 10g, coren oil 5 g
- Keywords
- golden rice carotenoids, healthy volunteers, retinol equivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
golden riceDietary supplement
Also called golden rice carotenoids
An acute dose of cooked golden rice containing ~ 1 mg of ß-carotene
corn oil 0gDietary supplement
0 g of corn oil in the golden rice meal
corn oil 10gDietary supplement
10g corn oil in the golden rice meal
coren oil 5 gDietary supplement
golden rice meal with 5 g corn oil
| Study group | Role | What they receive |
|---|---|---|
| Golden rice meal with 10g fat | Other | 10 g corn oil in the Golden Rice meal Receives: Dietary Supplement: golden rice; Dietary Supplement: corn oil 10g |
| Golden Rice with 0g fat | Other | 0g corn oil eating with the Golden Rice meal Receives: Dietary Supplement: golden rice; Dietary Supplement: corn oil 0g |
| Golden Rice meal with 5 g fat | Other | 5 g corn oil in the Golden Rice meal Receives: Dietary Supplement: golden rice; Dietary Supplement: coren oil 5 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
The enrichment of labeled golden rice β-carotene and its conversion to labeled retinol in serum samples after the golden rice meal with 0, 5, or 10 g fat (butter) as compared to the reference dose of vitamin A that is labeled differently.
Measured: 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2008 (estimated)
- Study startAug 2004
- Primary completionAug 2012
- Study completionAug 2012
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 HealthyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guangwen Tang, Ph. D, Tufts University
- Investigators
- Guangwen Tang, Ph. D, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680355
- Sponsor's protocol ID
- 59-1956-6-656
- Status last verified
- Jun 2013
- First submitted
- 16 May 2008
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang G, Qin J, Dolnikowski GG, Russell RM, Grusak MA. Golden Rice is an effective source of vitamin A. Am J Clin Nutr. 2009 Jun;89(6):1776-83. doi: 10.3945/ajcn.2008.27119. Epub 2009 Apr 15.
PubMed 19369372
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Golden Rice Carotenoids in Humans
- ClinicalTrials.gov ID
- NCT00680355
- Acronym / sponsor ID
- 59-1956-6-656
- Conditions
- Healthy
- Keywords
- golden rice carotenoids, healthy volunteers, retinol equivalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 May 2008 (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 investigation protocol uses an isotope reference method to evaluate bioavailability of ß-C in rice and its bioconversion to vitamin A.
A well-nourished population will be fed hydroponically grown Golden Rice containing ~ 1 mg of β-carotene at day 8 after a reference dose of vitamin A at day 1. The blood samples will be collected up to 33 days after the doses. The absorption kinetics will be determined by tracking both vitamin A and β-carotene in human serum. Blood responses to Golden Rice β-carotene will be determined and evaluated. The vitamin A value of Golden Rice can thus be quantitatively determined.
Detailed description
Recently, scientists have genetically engineered "golden rice" that contains 1.6 ug ß-carotene in a gram of dry rice (12). Since the vitamin A equivalency varies from 2 ug (oil dose) to 27 ug (vegetable) carotene to 1 retinol equivalent and the equivalency is matrix dependent, it is necessary to know what the vitamin A equivalency of golden rice beta-carotene is. The determination of the absorption and conversion of golden rice beta-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.
To evaluate the absorption and intestinal conversion of rice beta-carotene after an acute dose of golden rice, an intrinsically labeled Golden Rice with a labeled reference dose of vitamin A are used. We propose to conduct a pilot study on the US adults with normal vitamin A status (n = 15).
The specific aims of this pilot study are:
- To determine ß-carotene response kinetics following a meal of golden rice with 0, 5, or 10 g fat (butter);
- To determine retinol kinetics from the golden rice and from the labeled vitamin A dose;
- To determine vitamin A value of golden rice ß-carotene in adults with normal vitamin A status. The determination of the absorption and conversion of golden rice ß-carotene is of importance for designing food programs in many rice-eating regions of the world, where vitamin A deficiency is common.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Golden rice meal with 10g fat | Other | Dietary Supplement: golden rice, Dietary Supplement: corn oil 10g10 g corn oil in the Golden Rice meal |
| Golden Rice with 0g fat | Other | Dietary Supplement: golden rice, Dietary Supplement: corn oil 0g0g corn oil eating with the Golden Rice meal |
| Golden Rice meal with 5 g fat | Other | Dietary Supplement: golden rice, Dietary Supplement: coren oil 5 g5 g corn oil in the Golden Rice meal |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy health
Key exclusion criteria (1 listed)
- GI track problems
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 |
|---|---|---|
| golden riceAlso: golden rice carotenoidsAn acute dose of cooked golden rice containing ~ 1 mg of ß-carotene | Dietary supplement | Golden Rice meal with 5 g fat, Golden Rice with 0g fat, Golden rice meal with 10g fat |
| corn oil 0g0 g of corn oil in the golden rice meal | Dietary supplement | Golden Rice with 0g fat |
| corn oil 10g10g corn oil in the golden rice meal | Dietary supplement | Golden rice meal with 10g fat |
| coren oil 5 ggolden rice meal with 5 g corn oil | Dietary supplement | Golden Rice meal with 5 g fat |
Primary outcome
The enrichment of labeled golden rice β-carotene and its conversion to labeled retinol in serum samples after the golden rice meal with 0, 5, or 10 g fat (butter) as compared to the reference dose of vitamin A that is labeled differently.
Time frame: 33 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 1 Jul 2013.
- Derived from this study: PubMed 19369372Tang G, Qin J, Dolnikowski GG, Russell RM, Grusak MA. Golden Rice is an effective source of vitamin A. Am J Clin Nutr. 2009 Jun;89(6):1776-83. doi: 10.3945/ajcn.2008.27119. Epub 2009 Apr 15.
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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.
Guangwen Tang, Ph. D principal investigator
Tufts 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 golden rice, corn oil 0g and corn oil 10g in people with Healthy, run by Tufts 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 1 inclusion and 1 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 1 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.
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?
The enrichment of labeled golden rice β-carotene and its conversion to labeled retinol in serum samples after the golden rice meal with 0, 5, or 10 g fat (butter) as compared to the reference dose of vitamin A that is labeled differently. (time frame: 33 days). 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 NCT00680355, 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 1 Jul 2013.