HealthyNCT01633450
Zinc Absorption From Biofortified Rice
A study testing Zinc biofortified rice and Rice extrinsically fortified with zinc in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Zinc biofortified rice and Rice extrinsically fortified with zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female of 18 to 45 years old
- Body Mass Index in the range of 19 to 25
- No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study
Who cannot join
- Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
- Long-term medication during the whole study (except for contraceptives)
- Pregnancy
- Lactation
- Intention to become pregnant during the course of the study
- Lack of safe contraception
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st - Earlier participation in any nutrition study using Zn stable isotopes as well as participation in any other clinical study within the last 30 days and during this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study
One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.
- Conditions
- Healthy
- Being tested
- Zinc biofortified rice, Rice extrinsically fortified with zinc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc biofortified riceOther
1.12 mg zinc per meal
Rice extrinsically fortified with zincOther
1.12 mg zinc per meal
| Study group | Role | What they receive |
|---|---|---|
| Zinc biofortified rice | Experimental | Not described Receives: Other: Zinc biofortified rice |
| Rice extrinsically fortified with zinc | Active comparator | Not described Receives: Other: Rice extrinsically fortified with zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional absorption of zinc
Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry.
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 posted4 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionOct 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01633450
- Sponsor's protocol ID
- HNL/CTC12-Reis
- Status last verified
- Jun 2013
- First submitted
- 29 Jun 2012
- Last updated
- 7 Jun 2013
- Results posted
- No
Publications
Brnic M, Wegmuller R, Melse-Boonstra A, Stomph T, Zeder C, Tay FM, Hurrell RF. Zinc Absorption by Adults Is Similar from Intrinsically Labeled Zinc-Biofortified Rice and from Rice Fortified with Labeled Zinc Sulfate. J Nutr. 2016 Jan;146(1):76-80. doi: 10.3945/jn.115.213421. Epub 2015 Dec 16.
PubMed 26674764
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability of Zinc From Rice Biofortified With 70Zn and Rice Extrinsically Labeled With 70Zn in Young Adults: a Randomized, Single-blind Study
- ClinicalTrials.gov ID
- NCT01633450
- Acronym / sponsor ID
- HNL/CTC12-Reis
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 4 Jul 2012 (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.
One of the newest strategies to combat micronutrient deficiencies is the biofortification of staple foods, where higher levels of minerals are obtained through breeding of staple crops. The aim of this study is to evaluate zinc absorption from a rice biofortified with zinc when compared with a control rice fortified with zinc just before consumption.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc biofortified rice | Experimental | Other: Zinc biofortified rice |
| Rice extrinsically fortified with zinc | Active comparator | Other: Rice extrinsically fortified with zinc |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female of 18 to 45 years old
- Body Mass Index in the range of 19 to 25
- No mineral and vitamin supplements two weeks prior to the study and during the whole duration of the study
Key exclusion criteria (7 listed)
- Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
- Long-term medication during the whole study (except for contraceptives)
- Pregnancy
- Lactation
- Intention to become pregnant during the course of the study
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 |
|---|---|---|
| Zinc biofortified rice1.12 mg zinc per meal | Other | Zinc biofortified rice |
| Rice extrinsically fortified with zinc1.12 mg zinc per meal | Other | Rice extrinsically fortified with zinc |
Primary outcome
Fractional absorption of zinc
Time frame: 33 days
Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry.
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 7 Jun 2013.
- Derived from this study: PubMed 26674764Brnic M, Wegmuller R, Melse-Boonstra A, Stomph T, Zeder C, Tay FM, Hurrell RF. Zinc Absorption by Adults Is Similar from Intrinsically Labeled Zinc-Biofortified Rice and from Rice Fortified with Labeled Zinc Sulfate. J Nutr. 2016 Jan;146(1):76-80. doi: 10.3945/jn.115.213421. Epub 2015 Dec 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc biofortified rice and Rice extrinsically fortified with zinc in people with Healthy, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 7 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 7 Jun 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 Switzerland. 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?
Fractional absorption of zinc (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 NCT01633450, 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 7 Jun 2013.