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

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.