Examining the effectiveness of consuming flour made from agronomically biofortified wheat (Zincol-2016/NR-421) for improving Zn status in women in a low resource setting Pakistan: Study protocol for a randomised, double blind, controlled cross over trial (BiZiFED)

Abstract

Introduction: Dietary zinc (Zn) deficiency is a global problem, particularly in low and middle-income countries where access to rich, animal-source foods of Zn is limited due to poverty. In Pakistan, Zn deficiency affects over 40% of the adult female population, resulting in sub-optimal immune status and increased likelihood of complications during pregnancy.
Methods and analysis: We are conducting a double blind, randomised controlled feeding study with crossover design, in a low resource setting in Pakistan. Households were provided with flour milled from genetically and agronomically biofortified grain (Zincol-2016/NR-421) or control grain (Galaxy-2013. Fifty households were recruited. Each household included a female aged 16-49 years who is neither pregnant nor breastfeeding, and not currently consuming nutritional supplements. These women were the primary study participants. All households were provided with control flour for an initial 2-week baseline period, followed by an 8-week intervention period where 25 households receive biofortified flour (Group A) and 25 households receive control flour (Group B). After this eight-week period, Group A and B crossed over, receiving control and biofortified flour respectively for eight weeks. Tissue (blood, hair and nails) have been collected from the women at five time points: baseline, mid and end of period 1, mid and end of period 2.
Ethics and dissemination: Ethical approval was granted from the lead University (reference number: STEMH 697 FR) and the collaborating institution in Pakistan. The final study methods (including any modifications) will be published in peer reviewed journals, alongside the study outcomes on completion of the data analysis. In addition, findings will be disseminated to the scientific community via conference presentations and abstracts and communicated to the study participants through the village elders at an appropriate community forum.