Fractional Absorption of Zinc (Focus of the Study)NCT01636583
Zinc Absorption From Fortified Water
A study testing LSF water without meal, LSF water and inhibitory meal and Fortified inhibitory meal with water in people with Fractional Absorption of Zinc (Focus of the Study), run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
A water purifying system, called LifeStrawFamily (LSF), able to fortify water with zinc to a concentration of 4 mg/l has been developed. The aim of this study is to investigate whether the LSF strategy is advantageous in terms of zinc absorption compared to food fortification. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Fractional Absorption of Zinc (Focus of the Study)
- What is being tested?
- LSF water without meal, LSF water and inhibitory meal and Fortified inhibitory meal with water
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2012to Sep 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
- Signed informed consent
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
- Vegans
- Smoking
- Pregnancy
- Lactating
Show all 11Show fewer
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as:
- Female subjects of childbearing potential, not using and not willing to use a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Consumption of mineral and vitamin supplements within 2 weeks prior to 1st test meal administration
- 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.
Switzerland1 site
Clinical Trials Center, University Hospital
Zurich, Canton of Zurich, 8091
About this study
Official title: Zinc Absorption From Enriched Drinking Water Compared With the Zinc Absorption From a Fortified Maize Pudding in Healthy Young Adults.
A water purifying system, called LifeStrawFamily (LSF), able to fortify water with zinc to a concentration of 4 mg/l has been developed. The aim of this study is to investigate whether the LSF strategy is advantageous in terms of zinc absorption compared to food fortification. This study wants to demonstrate whether aqueous zinc produced by the LSF device consumed within or outside meals is better absorbed than zinc from an enriched cereal-based staple food in healthy adults. In addition, the zinc absorption from the LSF-enriched water and from a fortified inhibitory cereal-based pudding will be compared.
Read the detailed description
Zinc bioavailability from a food or diet depends on the content of zinc and the presence of inhibitors of zinc absorption, e.g. inositol phosphate, also known as phytic acid (PA), and it is typically estimated with the phytate to zinc molar ratio (Phy:Zn). A zinc absorption of 10-15% is estimated from diets containing mainly unrefined cereal grains or legumes with negligible amounts of animal proteins, which are dominant in developing countries (characterised by a Phy:Zn > 15). For comparison, a mixed animal and plant product diet (Phy:Zn ranging 5-15) is estimated to have an average zinc bioavailability of 20-30% whereas a diet with ample refined cereals and rich in animal foods (Phy:Zn < 5) would have average zinc bioavailability of 30-50% (12, 19). Fractional absorption from aqueous zinc sulphate or zinc chloride solutions taken in a fasting state has been shown to range 56-74% for doses of 0.5-10 mg zinc (20-24) and decreasing to 37-62% for doses of 13-30.1 mg zinc (22, 24). Zinc from drinking water consumed away from meals appears to be substantially better absorbed than that from composite foods. Alternative strategies, designed for providing zinc through the water supply, could prove useful in the global effort to control zinc deficiency.
To investigate whether zinc eluted from Lifestraw Family® (LSF) device via its specific zinc delivery system is more bioavailable than zinc from fortified cereals as zinc sulphate, we will perform a human absorption study based on the double isotopic tracer ratio technique. The fractional absorption of zinc (FAZ) from LSF-fortified water consumed with or without food will be compared to the FAZ from a fortified cereal. This will allow quantifying zinc bioavailability from the LSF eluted zinc 1) when LSF-water is consumed in fasting state 2) when LSF-water is consumed together with other foods 3) to compare the latter two with zinc absorption from a zinc fortified cereal.
The results of this study will provide information on the potential advantages of LSF fortification over zinc food fortification, which is currently the recommended delivery vehicle for zinc in country fortification programs (25, 26). Furthermore, comparing zinc bioavailability from LSF-water consumed alone or in combination with food will instruct about the optimal way to consume it. This information can be used to optimally design the delivery strategy in the planned efficacy trials. In the future, this information could also be integrated in the information recommendations for use for prospective end-consumers.
- Being tested
- LSF water without meal, LSF water and inhibitory meal, Fortified inhibitory meal with water
- Keywords
- zinc, absorption, bio-availability, aqueous zinc, zinc deficiency, zinc fortification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSF water without mealDevice
Composition of test meal: 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 1 mg of eluted Zn from LSF device of natural isotopic composition)
LSF water and inhibitory mealDevice
Composition of test meal: Maize porridge and 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 0.44 mg of eluted Zn from LSF device of natural isotopic composition)
Fortified inhibitory meal with waterOther
Composition of test meal: Maize porridge (1 mg 67Zn as ZnSO4 + 0.44 mg Zn as ZnSO4 of natural isotopic composition) and high purity water
| Study group | Role | What they receive |
|---|---|---|
| LSF water without meal | Experimental | Composition of test meal: 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 1 mg of eluted Zn from LSF device of natural isotopic composition) Receives: Device: LSF water without meal |
| LSF water and inhibitory meal | Active comparator | Composition of test meal: Maize porridge and 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 0.44 mg of eluted Zn from LSF device of natural isotopic composition) Receives: Device: LSF water and inhibitory meal |
| Fortified inhibitory meal with water | Active comparator | Composition of test meal: Maize porridge (1 mg 67Zn as ZnSO4 + 0.44 mg Zn as ZnSO4 of natural isotopic composition) and high purity water Receives: Other: Fortified inhibitory meal with water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional absorption (FA) of oral zinc isotope
A spot urine sample will be collected at baseline (day 1) and 96+/-3 hours (at day 5) after test meal administration and will be used to quantify zinc FA from the test meal. The FA from the zinc enriched LSF water consumed with and without food will be compared with the FA from the zinc fortified cereal.
Measured: At baseline (day 1) and day 5.
Secondary outcomes (2)
Plasma zinc (PZn)
Plasma zinc (PZn)concentration in blood samples will be analysed. PZn will be used to indicate if a participant is zinc deficient and therefore its absorption value from the test meals have to be treated with caution. PZn values will be compared to the corresponding cut-off values.
Measured: day 1
C-reactive protein (CRP)
C-reactive protein (CRP) concentration in blood samples will be analysed. CRP will indicate the inflammation/infection status of the subject at time of screening. Inflammation/infection is a confounder of zinc deficiency.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionSep 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 Fractional Absorption of Zinc (Focus of the Study)Studies 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
- None (open label)
- Enrolment
- 18 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
- Investigators
- Michael B Zimmermann, MD, Study chair, ETH, Laboratory of Human NutritionDiego Moretti, Dr., Principal investigator, ETH, Laboratory of Human Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636583
- Sponsor's protocol ID
- HNL/CTC_LSFZn
- Status last verified
- Nov 2012
- First submitted
- 29 Jun 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Galetti V, Kujinga P, Mitchikpe CE, Zeder C, Tay F, Tossou F, Hounhouigan JD, Zimmermann MB, Moretti D. Efficacy of highly bioavailable zinc from fortified water: a randomized controlled trial in rural Beninese children. Am J Clin Nutr. 2015 Nov;102(5):1238-48. doi: 10.3945/ajcn.115.117028. Epub 2015 Oct 14.
PubMed 26468121
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Absorption From Enriched Drinking Water Compared With the Zinc Absorption From a Fortified Maize Pudding in Healthy Young Adults.
- ClinicalTrials.gov ID
- NCT01636583
- Acronym / sponsor ID
- HNL/CTC_LSFZn
- Keywords
- zinc, absorption, bio-availability, aqueous zinc, zinc deficiency, zinc fortification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 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
- Sep 2012 (actual)
- First posted
- 10 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.
A water purifying system, called LifeStrawFamily (LSF), able to fortify water with zinc to a concentration of 4 mg/l has been developed. The aim of this study is to investigate whether the LSF strategy is advantageous in terms of zinc absorption compared to food fortification. This study wants to demonstrate whether aqueous zinc produced by the LSF device consumed within or outside meals is better absorbed than zinc from an enriched cereal-based staple food in healthy adults. In addition, the zinc absorption from the LSF-enriched water and from a fortified inhibitory cereal-based pudding will be compared.
Detailed description
Zinc bioavailability from a food or diet depends on the content of zinc and the presence of inhibitors of zinc absorption, e.g. inositol phosphate, also known as phytic acid (PA), and it is typically estimated with the phytate to zinc molar ratio (Phy:Zn). A zinc absorption of 10-15% is estimated from diets containing mainly unrefined cereal grains or legumes with negligible amounts of animal proteins, which are dominant in developing countries (characterised by a Phy:Zn > 15). For comparison, a mixed animal and plant product diet (Phy:Zn ranging 5-15) is estimated to have an average zinc bioavailability of 20-30% whereas a diet with ample refined cereals and rich in animal foods (Phy:Zn < 5) would have average zinc bioavailability of 30-50% (12, 19). Fractional absorption from aqueous zinc sulphate or zinc chloride solutions taken in a fasting state has been shown to range 56-74% for doses of 0.5-10 mg zinc (20-24) and decreasing to 37-62% for doses of 13-30.1 mg zinc (22, 24). Zinc from drinking water consumed away from meals appears to be substantially better absorbed than that from composite foods. Alternative strategies, designed for providing zinc through the water supply, could prove useful in the global effort to control zinc deficiency.
To investigate whether zinc eluted from Lifestraw Family® (LSF) device via its specific zinc delivery system is more bioavailable than zinc from fortified cereals as zinc sulphate, we will perform a human absorption study based on the double isotopic tracer ratio technique. The fractional absorption of zinc (FAZ) from LSF-fortified water consumed with or without food will be compared to the FAZ from a fortified cereal. This will allow quantifying zinc bioavailability from the LSF eluted zinc 1) when LSF-water is consumed in fasting state 2) when LSF-water is consumed together with other foods 3) to compare the latter two with zinc absorption from a zinc fortified cereal.
The results of this study will provide information on the potential advantages of LSF fortification over zinc food fortification, which is currently the recommended delivery vehicle for zinc in country fortification programs (25, 26). Furthermore, comparing zinc bioavailability from LSF-water consumed alone or in combination with food will instruct about the optimal way to consume it. This information can be used to optimally design the delivery strategy in the planned efficacy trials. In the future, this information could also be integrated in the information recommendations for use for prospective end-consumers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LSF water without meal | Experimental | Device: LSF water without mealComposition of test meal: 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 1 mg of eluted Zn from LSF device of natural isotopic composition) |
| LSF water and inhibitory meal | Active comparator | Device: LSF water and inhibitory mealComposition of test meal: Maize porridge and 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 0.44 mg of eluted Zn from LSF device of natural isotopic composition) |
| Fortified inhibitory meal with water | Active comparator | Other: Fortified inhibitory meal with waterComposition of test meal: Maize porridge (1 mg 67Zn as ZnSO4 + 0.44 mg Zn as ZnSO4 of natural isotopic composition) and high purity water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 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
- Signed informed consent
Key exclusion criteria (11 listed)
- Any metabolic, gastrointestinal or chronic disease (according to the subjects own statement)
- Long-term medication during the whole study (except for contraceptives
- Vegans
- Smoking
- Pregnancy
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 |
|---|---|---|
| LSF water without mealComposition of test meal: 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 1 mg of eluted Zn from LSF device of natural isotopic composition) | Device | LSF water without meal |
| LSF water and inhibitory mealComposition of test meal: Maize porridge and 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 0.44 mg of eluted Zn from LSF device of natural isotopic composition) | Device | LSF water and inhibitory meal |
| Fortified inhibitory meal with waterComposition of test meal: Maize porridge (1 mg 67Zn as ZnSO4 + 0.44 mg Zn as ZnSO4 of natural isotopic composition) and high purity water | Other | Fortified inhibitory meal with water |
Primary outcome
Fractional absorption (FA) of oral zinc isotope
Time frame: At baseline (day 1) and day 5.
A spot urine sample will be collected at baseline (day 1) and 96+/-3 hours (at day 5) after test meal administration and will be used to quantify zinc FA from the test meal. The FA from the zinc enriched LSF water consumed with and without food will be compared with the FA from the zinc fortified cereal.
2 secondary outcomes
Plasma zinc (PZn)
Time frame: day 1
C-reactive protein (CRP)
Time frame: day 1
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 8 Nov 2012.
- Derived from this study: PubMed 26468121Galetti V, Kujinga P, Mitchikpe CE, Zeder C, Tay F, Tossou F, Hounhouigan JD, Zimmermann MB, Moretti D. Efficacy of highly bioavailable zinc from fortified water: a randomized controlled trial in rural Beninese children. Am J Clin Nutr. 2015 Nov;102(5):1238-48. doi: 10.3945/ajcn.115.117028. Epub 2015 Oct 14.
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.
Michael B Zimmermann, MD study chair
ETH, Laboratory of Human Nutrition
Diego Moretti, Dr. principal investigator
ETH, Laboratory of Human Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSF water without meal, LSF water and inhibitory meal and Fortified inhibitory meal with water in people with Fractional Absorption of Zinc (Focus of the Study), 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 4 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 8 Nov 2012. 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 (FA) of oral zinc isotope (time frame: At baseline (day 1) and day 5.). 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 NCT01636583, 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 8 Nov 2012.