Acceptability and gut-modulatory effects of Finger millet-based complementary food (FMCF) in treating Indian children with Moderate Acute Malnutrition: A randomized controlled trial protocol

BackgroundUndernutrition among children under five remains a critical global health challenge, contributing to higher mortality. Traditional therapeutic foods often overlook the gut microbial derangements, critical for nutrient assimilation, growth, and long-term recovery. Finger millet, with its exceptional nutritional profile, stands as a sustainable alternative to cereal-based foods to address this nutritional gap while supporting gut-health and inflammation. ObjectivesThe aim of this study is to evaluate a Finger Millet-based Complementary Food (FMCF) as a nutrient-dense, safe, and acceptable intervention for moderately acute malnourished (MAM) children. MethodsFinger millet (GPU-28) was germinated, roasted, and gamma-irradiated to improve nutrient bioavailability, reduce antinutrients, and ensure microbial-safety. We enrolled 200 children (100 MAM, 100 Healthy controls) aged 18-59 months from Anganwadi Centres. Participants have been randomized to receive either FMCF or an equicaloric wheat-based control (Balamrutham+) for 8-weeks. Anthropometry, dietary intake, gut-microbiota composition, and inflammation marker estimation and correlation will be performed at different timepoints. ResultsProduct analysis revealed superior protein-energy ratio, fibre, calcium, and micronutrient content in FMCF compared to Balamrutham+. Microbiological and aflatoxin testing confirmed safety and shelf-life stability. Pilot feeding trial showed higher consumption (81-98%) and shorter eating times (53-71%, p<0.001). ConclusionFMCF is promising, cost-effective, and scalable intervention for nutritional-recovery in MAM, with potential to modulate the gut-microbiome and alleviate inflammation. The product aligns with SDG-2 (Zero Hunger) and SDG-3 (Good Health and Well-being), reinforcing its relevance as a public-health intervention. Approval and registrationInstitutional Ethics Committee (IEC)-CR/2/V/2023 and Clinical Trials Registry of India (CTRI)-CTRI/2023/06/053590.