The MFFAPP Tanzania Efficacy Study Protocol: Newly Formulated, Extruded, Fortified Blended Foods for Food Aid

Nicole M Delimont, Sirichat Chanadang, Michael V Joseph, Briana E Rockler, Qingbin Guo, Gregory K Regier, Michael R Mulford, Rosemary Kayanda, Mwita Range, Zidiheri Mziray, Ambaksye Jonas, Joseph Mugyabuso, Wences Msuya, Nina K Lilja, Sandra B Procter, Edgar Chambers 4th, Sajid Alavi, Brian L Lindshield, Nicole M Delimont, Sirichat Chanadang, Michael V Joseph, Briana E Rockler, Qingbin Guo, Gregory K Regier, Michael R Mulford, Rosemary Kayanda, Mwita Range, Zidiheri Mziray, Ambaksye Jonas, Joseph Mugyabuso, Wences Msuya, Nina K Lilja, Sandra B Procter, Edgar Chambers 4th, Sajid Alavi, Brian L Lindshield

Abstract

Fortified blended foods (FBFs) are micronutrient-fortified blends of milled cereals and pulses that represent the most commonly distributed micronutrient-fortified food aid. FBFs have been criticized due to lack of efficacy in treating undernutrition, and it has also been suggested that alternative commodities, such as sorghum and cowpea, be investigated instead of corn and soybean. The Micronutrient Fortified Food Aid Pilot Project (MFFAPP) Tanzania efficacy study was the culmination of economic, processing, sensory, and nutrition FBF research and development. MFFAPP Tanzania was a 20-wk, partially randomized cluster design conducted between February and July 2016 that enrolled children aged 6-53 mo in the Mara region of Tanzania with weight-for-height z scores >-3 and hemoglobin concentrations <10.3 mg/dL. The intervention was complementary feeding of newly formulated, extruded FBFs (white sorghum cowpea variety 1, white sorghum-cowpea variety 2, red sorghum-cowpea, white sorghum-soy blend, and corn-soy blend 14) compared with Corn Soy Blend Plus (CSB+), a current US Agency for International Development-distributed corn-soy blend, and a no-FBF-receiving control. Screened participants (n = 2050) were stratified by age group (6-23 and 24-53 mo) and allocated to 1 of 7 FBF clusters provided biweekly. Biochemical and anthropometric data were measured every 10 wk at weeks 0, 10, and 20. The primary objectives of this study were to determine whether newly formulated, extruded corn-, soy-, sorghum-, and cowpea-based FBFs result in equivalent vitamin A or iron outcomes compared with CSB+. Changes in anthropometric outcomes were also examined. Results from the MFFAPP Tanzania Efficacy Study will inform food aid producers and distributers about whether extruded sorghum- and cowpea-based FBFs are viable options for improving the health of the undernourished. This trial was registered at clinicaltrials.gov as NCT02847962.

Keywords: cowpea; extrusion; food aid; fortified blended food; iron; protein; sorghum; undernutrition; vitamin A.

Figures

FIGURE 1
FIGURE 1
Map of the Tanzanian region for the efficacy study. The Mara region was chosen due to the prevalence of stunting, wasting, and vitamin A and iron deficiency. DISP, dispensary. Map data: Google, DigitalGlobe.
FIGURE 2
FIGURE 2
Location of health facilities and clusters in the Mara region. Clusters were grouped by age and geographic location of health facilities to avoid crossover of treatments. Map data: Google, DigitalGlobe.
FIGURE 3
FIGURE 3
Correlation between invasive (Hemocue 201+) and noninvasive (Massimo Pronto-7) Hb monitoring used for screening procedures (n = 419). Correlation was poor (R2 = 0.46; all data) in the upper and lower tertiles of Hb values, prompting lower Hb inclusion criteria. Hb, hemoglobin.
FIGURE 4
FIGURE 4
Agreement between invasive (Hemocue 201+) and noninvasive (Massimo Pronto-7) monitoring for inclusion criteria at different hemoglobin cutoffs (n = 419). Values are presented as the percentage of agreement in participants below a given hemoglobin cutoff value. Inclusion criteria agreement between the 2 hemoglobin measurement tools improved with cutoffs <10.3 mg/dL (91% agreement) compared with 11 mg/dL (65% agreement).
FIGURE 5
FIGURE 5
Screening, exclusion, and inclusion criteria for randomization. Participants within study age ranges were excluded for restrictions in travel, relocation, and exclusive breastfeeding. Other participants were excluded if they had a weight-for-height z score <−3 or hemoglobin >10.3 mg/dL.

References

    1. World Food Programme Types of malnutrition [Internet] [updated 2016; cited 2015 Jul 14]. Available from: .
    1. UNICEF Levels and trends in child malnutrition UNICEF-WHO-World Bank Group joint child malnutrition estimates: key findings of the 2015 edition. New York: UNICEF, WHO, World Bank Group; 2015.
    1. Hawkes C, Haddad L, Udomkesmalee E... The Global Nutrition Report 2015: what we need to do to advance progress in addressing malnutrition in all its forms. Public Health Nutr 2015;18:3067–9.
    1. Camaschella C. Iron-deficiency anemia. N Engl J Med 2015;372:1832–43.
    1. Stevens GA, Finucane MM, De-Regil L, Paciorek CJ, Flaxman SR, Branca F, Peña-Rosas JP, Bhutta ZA, Ezzati M.. Global, regional, and national trends in haemoglobin concentration and prevalence of total and severe anaemia in children and pregnant and non- pregnant women for 1995– 2011: a systematic analysis of population- representative data. Lancet Glob Health 2013;1:e16–25.
    1. UNICEF Improving child nutrition: the achievable imperative for global progress. New York: United Nations Publications; 2013.
    1. Webb P, Rogers BL, Rosenberg I, Schlossman N, Wanke C, Bagriansky J, Sadler K, Johnson Q, Tilahun J, Masterson AR.. Improving the nutritional quality of US food aid: recommendations for changes to products and programs. Boston: Tufts University; 2011.
    1. World Food Programme Special nutrition products [Internet] [cited 2016 Feb 2]. Rome (Italy): World Food Programme; 2016 [cited 2016 Jun 26]. Available from: .
    1. Ackatia-Armah RS, McDonald CM, Doumbia S, Erhardt JG, Hamer DH, Brown KH.. Malian children with moderate acute malnutrition who are treated with lipid-based dietary supplements have greater weight gains and recovery rates than those treated with locally produced cereal-legume products: a community-based, cluster-randomized trial. Am J Clin Nutr 2015;101:632–45.
    1. Pérez-Expósito AB, Klein BP.. Impact of fortified blended food aid products on nutritional status of infants and young children in developing countries. Nutr Rev 2009;67:706–18.
    1. USDA Commodity requirements corn soy blend plus [Internet]. 2014. [cited 2015 Jul 7]. Available from: .
    1. Taylor JN. Overview: importance of sorghum in Africa. Afripro: Workshop on the Proteins of Sorghum and Millets: Enhancing Nutritional and Functional Properties for Africa, University of Pretoria; Vol. 2 No. 4; 2003.
    1. International Institute for Tropical Agriculture Cowpea [Internet] [cited 2015 Jun 9]. Available from: .
    1. Hurrell RF, Reddy MB, Juillerat MA, Cook JD.. Degradation of phytic acid in cereal porridges improves iron absorption by human subjects. Am J Clin Nutr 2003;77:1213–9.
    1. MacLeon WC, Lopez de Romaña G, Placko RP, Graham GG.. Protein quality and digestibility of sorghum in preschool children: balance studies and plasma free amino acids. J Nutr 1981;111:1928–36.
    1. Tran QD, Hendriks WH, Van DP.. Effects of extrusion processing on nutrients in dry pet food. J Sci Food Agric 2008;88:1487–93.
    1. Mertz ET, Hassen MM, Cairns-Whittern C, Kirleis AW, Tu L, Axtell JD.. Pepsin digestibility of proteins in sorghum and other major cereals. Proc Natl Acad Sci USA 1984;81:1–2.
    1. Rosenberg I, Rogers B, Webb P, Schlossman N.. Enhancements in food aid quality need to be seen as a process, not as a one-off event. J Nutr 2012;142:1781.
    1. Ministry of Health, Community Development, Gender, Elderly and Children [Tanzania Mainland]; Ministry of Health [Zanzibar]; National Bureau of Statistics; Office of the Chief Government Statistician; ICF International. Tanzania Demographic and Health Survey and Malaria Indicator Survey (TDHS- MIS) 2015–16. Dar es Salaam (Tanzania) and Rockville (MD): Ministry of Health, Community Development, Gender, Elderly and Children; Ministry of Health; National Bureau of Statistics; Office of the Chief Government Statistician; and ICF International; 2016.
    1. National Bureau of Statistics [Tanzania]; ICF Macro Tanzania Demographic and Health Survey, 2010. Dar es Salaam (Tanzania): National Bureau of Statistics and ICF Macro; 2011.
    1. Tanzania Food and Nutrition Centre The United Repuplic of Tanzania Ministry of Health and Social Welfare Tanzania National Nutritional Survey 2014. Dar es Salaam (Tanzania): Tanzania Food and Nutrition Centre; 2014.
    1. WHO The WHO Child Growth Standards [Internet] [cited 2016 Feb 5]. Available from: .
    1. WHO Haemoglobin concentrations for the diagnosis of anaemia and assessment of severity [Internet] [cited 2016 Feb 5]. Geneva (Switzerland): WHO; 2011. (Publication HO/NMH/NHD/MnM/11.1.) Available from: .
    1. USDA USDA commodity requirements: CSB13 corn-soy blend for use in export programs [Internet] 2007. [cited 2015 Jul 7]. Available from: .
    1. Delimont NM, Fiorentino NM, Opoku-Acheampong AB, Joseph MV, Guo Q, Alavi S, Lindshield BL.. Newly formulated, protein quality-enhanced, extruded sorghum-, cowpea-, corn-, soya-, sugar- and oil-containing fortified-blended foods lead to adequate vitamin A and iron outcomes and improved growth compared with non-extruded CSB+ in rats. J Nutr Sci 2017;6:e18.
    1. Karakochuk CD, Janmohamed A, Whitfield KC, Barr SI, Vercauteren SM, Kroeun H, Talukder A, Mclean J, Green TJ.. Evaluation of two methods to measure hemoglobin concentration among women with genetic hemoglobin disorders in Cambodia: a method- comparison study. Clin Chim Acta 2015;441:148–55.
    1. Andang'o PEA, Osendarp SJM, Ayah R, West CE, Mwaniki DL, De Wolf CA, Kraaijenhagen R, Kok FJ, Verhoef H.. Efficacy of iron-fortified whole maize flour on iron status of schoolchildren in Kenya: a randomised controlled trial. Lancet 2007;369:1799–806.
    1. Zhang X, Chen K, Qu P, Liu Y, Li T.. Effect of biscuits fortified with different doses of vitamin A on indices of vitamin A status, haemoglobin and physical growth levels of preschool children in Chongqing. Public Health Nutr 2010;13:1462–71.
    1. Victora CG, de Onis M, Hallal PC, Blössner M, Shrimpton R.. Worldwide timing of growth faltering: revisiting implications for interventions. Pediatrics 2010;125:e473.
    1. Rosenberg J. Improving child nutrition to decrease stunting. Int Perspect Sex Reprod Health 2013;39:57.
    1. De Onis M. WHO Child Growth Standards: length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for age: methods and development. Geneva (Switzerland): WHO; 2006.
    1. Fujita M, Brindle E, Shofer J, Ndemwa P, Kombe Y, Shell-Duncan B, O'Connor K.. Retinol-binding protein stability in dried blood spots. Clin Chem 2007;53:1972–5.
    1. Garrett DA, Sangha JK, Kothari MT, Boyle D.. Field-friendly techniques for assessment of biomarkers of nutrition for development. Am J Clin Nutr 2011;94:685S.
    1. Larson LM, Addo OY, Sandalinas F, Faigao K, Kupka R, Flores-Ayala R, Suchdev PS.. Accounting for the influence of inflammation on retinol-binding protein in a population survey of Liberian preschool-age children. Matern Child Nutr 2017;13:e12298.
    1. Suchdev PS, Namaste SM, Aaron GJ, Raiten DJ, Brown KH, Flores-Ayala R; BRINDA Working Group . Overview of the Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia (BRINDA) Project. Adv Nutr 2016;7:349–56.
    1. Baingana R, Matovu-Kasozi D, Garrett D.. The importance of controlling for the acute-phase response in the population- based assessment of vitamin A status: a study in children of pre- school age in Uganda. Public Health Nutr 2013;16:1540–7.
    1. Gorstein JL, Dary O, Shell-Duncan B, Quick T, Wasanwisut E.. Feasibility of using retinol-binding protein from capillary blood specimens to estimate serum retinol concentrations and the prevalence of vitamin A deficiency in low-resource settings. Public Health Nutr 2008;11:513–20.
    1. Osazuwa F, Oguntade MA, Imade P.. A significant association between intestinal helminth infection and anaemia burden in children in rural communities of Edo state, Nigeria. N Am J Med Sci 2011;3:30–4.
    1. Akanni EO, Adefioye OA, Akanni RA, Taiwo SS.. Iron deficiency anaemia associated with helminths and asymptomatic malaria infections among rural school children in southwestern Nigeria. Asian Pac J Trop Dis 2014;4:S590–4.
    1. WHO/UNICEF Joint Monitoring Programme Improved and unimproved water and sanitation sources [Internet]. c2016. [cited 2017 Jan 25]. Available from: .
    1. Dearden KA, Schott W, Crookston BT, Humphries DL, Penny ME, Behrman JR.. Children with access to improved sanitation but not improved water are at lower risk of stunting compared to children without access: a cohort study in Ethiopia, India, Peru, and Vietnam. BMC Public Health 2017;17:110.

Source: PubMed

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

3
Abonner