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Table 2 Arms and Interventions

From: Developing shelf-stable Microbiota Directed Complementary Food (MDCF) prototypes for malnourished children: study protocol for a randomized, single-blinded, clinical study

 

Arms

Intervention

1

Active Comparator: Central kitchen-prepared MDCF-2. Children randomized to this arm will receive 25g of kitchen-prepared version of MDCF-2 twice daily.

Dietary Supplement: Central kitchen-prepared version of MDCF-2. Kitchen-prepared MDCF-2 containing chickpea flour, peanut flour, soybean flour, green banana pulp, sugar, soybean oil and micronutrient mix. This version of MDCF-2 will be freshly prepared in a central kitchen on a daily basis and provided to participants on the same day.

2

Experimental: ‘Jump-start’ version of MDCF-2. Freshly reconstituted MDCF-2 ingredients. Children randomized to this arm will receive individually packaged MDCF-2 ingredients, combined into 21.7 g servings provided twice daily.

Dietary Supplement: Jump-start version of MDCF-2. Freshly reconstituted MDCF-2 ingredients. This version of MDCF-2 is comprised of its individually packaged ingredients. Separate premeasured sachets of chickpea flour, peanut paste, soybean flour, green banana powder, sugar, soybean oil and micronutrient mix will be combined and reconstituted prior to each feeding session.

3

Experimental: MDCF-2 shelf-stable foil pouch prototype with green banana powder. Children randomized to this arm will receive 25g of the shelf-stable foil pouch prototype with green banana powder twice daily.

Dietary Supplement: MDCF-2 shelf-stable foil pouch prototype with green banana powder. This shelf-stable foil pouch prototype of MDCF-2 contains chickpea flour, peanut flour, soybean flour, green banana powder, sugar, soybean oil and micronutrient mix, prepared by an industry partner following the formulation developed at icddr,b.

4

Experimental: MDCF-2 shelf-stable foil pouch prototype with sweet potato. Children randomized to this arm will receive 23.3g of this MDCF prototype with sweet potato twice daily.

Dietary Supplement: MDCF-2 shelf-stable foil pouch prototype with sweet potato. This shelf-stable MDCF prototype contains chickpea flour, peanut flour, soybean flour, sweet potato, sugar, soybean oil and micronutrient mix. This version of MDCF-2 will be prepared by an industry partner following the formulation developed at icddr,b.

5

Experimental: Ready-to-use supplementary food (RUSF). Children randomized to this arm will receive 25g RUSF twice daily.

Dietary Supplement: Ready-to-use supplementary food (RUSF) arm. Locally-produced ready-to-use supplementary food (RUSF) is used as part of a nutritional program to treat moderate acute malnutrition in children over 6 months-of-age. RUSF is eaten directly from the package with no dilution, mixing or cooking. RUSF contains rice, lentil, powdered low-fat milk, soybean oil, sugar, and micronutrient mix.