Fractional Absorption of Zinc (Focus of the Study) Clinical Trial
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.
| Status | Completed |
| Enrollment | 18 |
| Est. completion date | September 2012 |
| Est. primary completion date | August 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Clinical Trials Center, University Hospital | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| Swiss Federal Institute of Technology | University of Zurich |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | At baseline (day 1) and day 5. | No |
| Secondary | 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. | day 1 | No |
| Secondary | 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. | day 1 | No |