(P02-025-25) Efficacy of Zinc Fortified and Fermented Wheat Flour (EZAFFAW): A Randomized Controlled Trial

Objectives: This RCT aims to evaluate the impact of agronomically zinc biofortified (fermented and non-fermented) and post-harvest wheat flour flatbread on zinc status and metabolic health in adolescents and adult women in rural Pakistan.

Methods: A four-arm triple-blind randomized controlled trial was conducted in a rural district of Pakistan. Participants (adolescents aged 10–19 and adult women aged 20–40) were assigned to receive fermented or unfermented high zinc agronomically biofortified wheat flour flatbread, post-harvest zinc-fortified wheat flour flatbread, or low zinc conventional whole wheat flour flatbread. the outcomes included serum zinc concentration, zinc deficiency, Body Mass Index (BMI, HbA1C, HOMA-IR and lipid profile. The meal was served once a day, six days a week for six months. This trial adhered to CONSORT guidelines for randomized trials, with primary analysis on an intention-to-treat basis The trial is registered with number NCT06092515.

Results: A total of 1044 participants were randomized to four study arms. The baseline characteristics of the participants of the four study arms were comparable. At endline all the groups showed improvement from their respective baseline levels for serum zinc, anthropometry and metabolic markers. The multivariable analysis suggests statistically significant differences among the four groups in HbA1C, fasting blood glucose and triglyceride levels, while there was no significant difference for serum zinc or BMI.

Conclusions: The results highlight the role of agronomically zinc biofortified wheat flour in improving zinc status and metabolic health. Findings may inform public health strategies to combat zinc deficiency in resource-limited settings.

Funding Sources: HarvestPlus