Zinc Absorption From Fortified Water

This study has been completed.
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01636583
First received: June 29, 2012
Last updated: November 7, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Fractional Absorption of Zinc (Focus of the Study)
Device: LSF water without meal
Device: LSF water and inhibitory meal
Other: Fortified inhibitory meal with water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Zinc Absorption From Enriched Drinking Water Compared With the Zinc Absorption From a Fortified Maize Pudding in Healthy Young Adults.

Resource links provided by NLM:


Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Fractional absorption (FA) of oral zinc isotope [ Time Frame: At baseline (day 1) and day 5. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Plasma zinc (PZn) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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.

  • C-reactive protein (CRP) [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LSF water without meal
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)
Device: LSF water without meal
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)
Active Comparator: LSF water and inhibitory meal
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)
Device: LSF water and inhibitory meal
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)
Active Comparator: Fortified inhibitory meal with water
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
Other: Fortified inhibitory meal with water
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636583

Locations
Switzerland
Clinical Trials Center, University Hospital
Zurich, Switzerland, 8091
Sponsors and Collaborators
Swiss Federal Institute of Technology
University of Zurich
Investigators
Study Chair: Michael B Zimmermann, MD ETH, Laboratory of Human Nutrition
Principal Investigator: Diego Moretti, Dr. ETH, Laboratory of Human Nutrition
  More Information

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr.med., Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01636583     History of Changes
Other Study ID Numbers: HNL/CTC_LSFZn
Study First Received: June 29, 2012
Last Updated: November 7, 2012
Health Authority: Switzerland: Federal Office of Public Health

Keywords provided by Swiss Federal Institute of Technology:
zinc
absorption
bio-availability
aqueous zinc
zinc deficiency
zinc fortification

ClinicalTrials.gov processed this record on October 23, 2014