Zinc DeficiencyNCT01775319
Evaluation of Human Zinc Absorption From Wheat-based Meals
A study testing Biofortified wheat and Fortified wheat in people with Zinc Deficiency, run by Swiss Federal Institute of Technology.
Trial summary
Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable isotope absorption studies in women of childbearing age consuming test meals prepared from either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two different extraction rates. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- Biofortified wheat and Fortified wheat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Mar 2014
- 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
- Female, 18 to 45 years old (Study part 1 and 2). Female or male, 18 to 45 years old (Study part 3)
- Body Mass Index in the range of 18.5 to 25 kg/m2
- Signed informed consent
Who cannot join
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, anemia, hepatitis, hypertension, cancer or cardiovascular diseases (according to the subjects own statement)
- Gluten intolerance, celiac disease
- Continuous/long-term use of medication during the whole study (except for contraceptives)
- Vegans
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st test meal administration
- Smoking
Show all 9Show fewer
- Pregnancy (Urine pregnancy test shall be performed before each test meal administration)
- Lactating
- Earlier participation in a study using Zn stable isotopes or participation in any other clinical study within the last 30 days
About this study
Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable isotope absorption studies in women of childbearing age consuming test meals prepared from either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two different extraction rates.
Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat: stable isotope absorption studies in women of childbearing age, or men, consuming test meals prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or post-harvest fortified wheat extrinsically labeled immediately before consumption.
Read the detailed description
The overall goal of study part 1 and 2 is to evaluate and compare the fractional and absolute Zn absorption from biofortified wheat cultivar (60 ppm Zn) to regular wheat (28 ppm Zn) and to post harvest fortified wheat (60 ppm Zn) for a total of 3 test meals per study. The studies will be conducted with products based on wheat with high extraction rate (study part 1) and medium extraction rate (study part 2) in two separate groups of women of childbearing age.
The goal of study part 3 is to investigate the difference of absorption measurements between intrinsically and extrinsically labeled biofortified wheat. The label of the test meals will have the same nature as the fortificant itself (extrinsic vs intrinsic), for a total of 3 test meals.
- Conditions
- Zinc Deficiency
- Being tested
- Biofortified wheat, Fortified wheat, Placebo
- Keywords
- Zinc
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofortified wheatDietary supplement
Also called Esperia
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
Fortified wheatDietary supplement
Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Biofortified wheat | Active comparator | Biofortified wheat Receives: Dietary Supplement: Biofortified wheat |
| Control wheat | Placebo comparator | Control wheat with low level of Zn Receives: Dietary Supplement: Placebo |
| Fortified wheat | Active comparator | Wheat fortified before consumption Receives: Dietary Supplement: Fortified wheat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional zinc absorption from different wheat-based test meals
Fractional zinc absorption (in %) will be assessed with stable isotopes of zinc using a double isotope technique.
Measured: 3 months
Secondary outcomes (1)
Zn and C-reactive protein concentration in plasma
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionMar 2014
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 Zinc DeficiencyStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- HarvestPlus
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Diego Moretti, PhD, Principal investigator, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01775319
- Sponsor's protocol ID
- HNL/CTC_Zn_wheat
- Other IDs
- KEK-ZH-2012-0483
- Status last verified
- Apr 2016
- First submitted
- 22 Jan 2013
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Signorell C, Zimmermann MB, Cakmak I, Wegmuller R, Zeder C, Hurrell R, Aciksoz SB, Boy E, Tay F, Frossard E, Moretti D. Zinc Absorption From Agronomically Biofortified Wheat Is Similar to Post-Harvest Fortified Wheat and Is a Substantial Source of Bioavailable Zinc in Humans. J Nutr. 2019 May 1;149(5):840-846. doi: 10.1093/jn/nxy328.
PubMed 31004128
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Human Zinc Absorption From Wheat-based Meals
- ClinicalTrials.gov ID
- NCT01775319
- Acronym / sponsor ID
- HNL/CTC_Zn_wheat
- Conditions
- Zinc Deficiency
- Keywords
- Zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- HarvestPlus
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Jan 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.
Study part 1 and 2 Assessment of Zn absorption from regular and biofortified wheat: stable isotope absorption studies in women of childbearing age consuming test meals prepared from either the biofortified Zn wheat, regular wheat or post-harvest fortified wheat at two different extraction rates.
Study part 3 Assessment of Zn absorption from intrinsically and extrinsically labeled wheat: stable isotope absorption studies in women of childbearing age, or men, consuming test meals prepared from either intrinsically labeled Zn biofortified wheat, regular wheat or post-harvest fortified wheat extrinsically labeled immediately before consumption.
Detailed description
The overall goal of study part 1 and 2 is to evaluate and compare the fractional and absolute Zn absorption from biofortified wheat cultivar (60 ppm Zn) to regular wheat (28 ppm Zn) and to post harvest fortified wheat (60 ppm Zn) for a total of 3 test meals per study. The studies will be conducted with products based on wheat with high extraction rate (study part 1) and medium extraction rate (study part 2) in two separate groups of women of childbearing age.
The goal of study part 3 is to investigate the difference of absorption measurements between intrinsically and extrinsically labeled biofortified wheat. The label of the test meals will have the same nature as the fortificant itself (extrinsic vs intrinsic), for a total of 3 test meals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biofortified wheat | Active comparator | Dietary Supplement: Biofortified wheatBiofortified wheat |
| Control wheat | Placebo comparator | Dietary Supplement: PlaceboControl wheat with low level of Zn |
| Fortified wheat | Active comparator | Dietary Supplement: Fortified wheatWheat fortified before consumption |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female, 18 to 45 years old (Study part 1 and 2). Female or male, 18 to 45 years old (Study part 3)
- Body Mass Index in the range of 18.5 to 25 kg/m2
- Signed informed consent
Key exclusion criteria (9 listed)
- Any metabolic, gastrointestinal kidney or chronic disease such as diabetes, anemia, hepatitis, hypertension, cancer or cardiovascular diseases (according to the subjects own statement)
- Gluten intolerance, celiac disease
- Continuous/long-term use of medication during the whole study (except for contraceptives)
- Vegans
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st test meal administration
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 |
|---|---|---|
| Biofortified wheatAlso: EsperiaExtrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose | Dietary supplement | Biofortified wheat |
| Fortified wheatExtrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose | Dietary supplement | Fortified wheat |
| Placebo | Dietary supplement | Control wheat |
Primary outcome
Fractional zinc absorption from different wheat-based test meals
Time frame: 3 months
Fractional zinc absorption (in %) will be assessed with stable isotopes of zinc using a double isotope technique.
1 secondary outcome
Zn and C-reactive protein concentration in plasma
Time frame: 3 months
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 14 Apr 2016.
- Derived from this study: PubMed 31004128Signorell C, Zimmermann MB, Cakmak I, Wegmuller R, Zeder C, Hurrell R, Aciksoz SB, Boy E, Tay F, Frossard E, Moretti D. Zinc Absorption From Agronomically Biofortified Wheat Is Similar to Post-Harvest Fortified Wheat and Is a Substantial Source of Bioavailable Zinc in Humans. J Nutr. 2019 May 1;149(5):840-846. doi: 10.1093/jn/nxy328.
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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.
Diego Moretti, PhD principal investigator
Swiss Federal Institute of Technology
Questions about this trial
What is this clinical trial studying?
A study testing Biofortified wheat and Fortified wheat in people with Zinc Deficiency, run by Swiss Federal Institute of Technology.
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 9 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 14 Apr 2016. 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. Some participants in this study may receive a placebo. 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 zinc absorption from different wheat-based test meals (time frame: 3 months). 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 NCT01775319, 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 14 Apr 2016.