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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 in 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-income 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 suboptimal immune status and increased likelihood of complications during pregnancy. METHODS AND ANALYSIS:We are conducting a double-blind, randomised controlled feeding study with cross-over 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 woman 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 8-week period, groups A and B crossed over, receiving control and biofortified flour respectively for 8?weeks. Tissue (blood, hair and nails) have been collected from the women at five time points: baseline, middle and end of period 1, and middle and end of period 2. ETHICS AND DISSEMINATION:Ethical approval was granted from the lead university (reference no. 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. REGISTRATION DETAILS:The trial has been registered with the ISRCTN registry, study ID ISRCTN83678069.

SUBMITTER: Lowe NM

PROVIDER: S-EPMC5905768 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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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 in Pakistan: study protocol for a randomised, double-blind, controlled cross-over trial (BiZiFED).

Lowe Nicola M NM Khan Muhammad Jaffar MJ Broadley Martin R MR Zia Munir H MH McArdle Harry J HJ Joy Edward J M EJM Ohly Heather H Shahzad Babar B Ullah Ubaid U Kabana Gul G Medhi Rashid R Afridi Mukhtiar Zaman MZ

BMJ open 20180417 4

<h4>Introduction</h4>Dietary zinc (Zn) deficiency is a global problem, particularly in low-income 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 suboptimal immune status and increased likelihood of complications during pregnancy.<h4>Methods and analysis</h4>We are conducting a double-blind, randomised controlled feeding study with cross-over design in a ...[more]

PMID: 29666141

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Project description:Background and aims:Use of zinc (Zn) fertilisers may be cost-effective in increasing crop yields and in alleviating dietary Zn deficiency. However, Zn fertilisers are underutilised in many countries despite the widespread occurrence of Zn-deficient soils. Here, increased Zn fertiliser-use scenarios were simulated for wheat production in Punjab and Sindh Provinces, Pakistan. Inputs and outputs were valued in terms of both potential yield gains as well as health gains in the population. Methods:The current dietary Zn deficiency risk of 23.9 % in Pakistan was based on food supply and wheat grain surveys. "Disability-adjusted life years (DALYs) lost" are a common metric of disease burden; an estimated 245,000 DALYs y-1 are lost in Punjab and Sindh due to Zn deficiency. Baseline Zn fertiliser-use of 7.3 kt y-1 ZnSO4.H2O was obtained from published and industry sources. The wheat area currently receiving Zn fertilisers, and grain yield responses of 8 and 14 % in Punjab and Sindh, respectively, were based on a recent survey of >2500 farmers. Increased grain Zn concentrations under Zn fertilisation were estimated from literature data and converted to improved Zn intake in humans and ultimately a reduction in DALYs lost. Results:Application of Zn fertilisers to the area currently under wheat production in Punjab and Sindh, at current soil: foliar usage ratios, could increase dietary Zn supply from ~12.6 to 14.6 mg capita -1 d-1, and almost halve the prevalence of Zn deficiency, assuming no other changes to food consumption. Gross wheat yield could increase by 2.0 and 0.6 Mt. grain y-1 in Punjab and Sindh, respectively, representing an additional return of US$ >800 M and an annual increased grain supply of 19 kg capita -1. Conclusions:There are potential market- and subsidy-based incentives to increase Zn fertiliser-use in Pakistan. Benefit-Cost Ratios (BCRs) for yield alone are 13.3 and 17.5 for Punjab and Sindh, respectively. If each DALY is monetised at one to three fold Gross National Income per capita on purchasing power parity (GNIPPP), full adoption of Zn fertiliser for wheat provides an additional annual return of 405-1216 M International Dollars (I$) in Punjab alone, at a cost per DALY saved of I$ 461-619.

Project description:A new variety of zinc biofortified wheat (Zincol-2016) was released in Pakistan in 2016. The primary aim of this study was to examine the effects of consuming Zincol-2016 wheat flour on biochemical and functional markers of zinc status in a population with widespread zinc deficiency. An individually-randomised, double-blind, placebo-controlled cross over design was used. Fifty households were recruited to participate in the study, with each household included at least one woman of reproductive age (16-49 years) who was neither pregnant nor breast feeding or currently taking nutritional supplements. All households were provided with control flour for an initial 2-week baseline period, followed by the intervention period where households were randomly allocated in a 1:1 ratio to receive biofortified flour (group A; n = 25) and control flour (group B; n = 25) for 8-weeks, then switched to the alternate flour for 8-weeks. The trial has been registered with the ISRCTN (https://www.isrctn.com), ID ISRCTN83678069. The primary outcome measure was plasma zinc concentration, and the secondary outcome measures were plasma selenium and copper concentrations, plasma copper:zinc ratio and fatty acid desaturase and elongase activity indices. Nutrient intake was assessed using 24-h dietary recall interviews. Mineral concentrations in plasma were measured using inductively coupled plasma mass spectrometry and free fatty acids and sphingolipids by mass spectrometry. Linear Mixed Model regression and General Linear Model with repeated measures were used to analyse the outcomes. Based on an average flour consumption of 224 g/day, Zincol-2016 flour provided an additional daily zinc intake of between 3.0 and 6.0 mg for white and whole grain flour, respectively. No serious adverse events were reported. This resulted in significant, increase in plasma zinc concentration after 4 weeks [mean difference 41.5 μg/L, 95% CI (6.9-76.1), p = 0.02]. This was not present after 8 weeks (p = 0.6). There were no consistent significant effects of the intervention on fatty acid desaturase and elongase activity indices. Regular consumption of Zincol-2016 flour increased the daily zinc intake of women of reproductive age by 30-60%, however this was not associated with a sustained improvement in indices of zinc status.

Dataset Information

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 in Pakistan: study protocol for a randomised, double-blind, controlled cross-over trial (BiZiFED).

Publications

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 in Pakistan: study protocol for a randomised, double-blind, controlled cross-over trial (BiZiFED).

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