The purpose of this study is to determine the health impacts of consistent consumption of insect-fortified crackers among school-aged children in Madagascar.
Specifically, in this RCT, the investigators will assess whether the insect-fortified crackers can improve the health status of Malagasy school children. The investigators' objectives are to: (1) Assess changes in gut microbiome composition that occur after 6 and 14 weeks of cracker consumption through 16S rRNA sequencing. (2) Assess changes in intestinal and systemic inflammation after 6 and 14 weeks of cracker consumption through quantification of fecal calprotectin, lactoferrin, myeloperoxidase (MPO), and alpha-1-antitrypsin (AAT) and circulating pro-inflammatory cytokines. (3) Assess changes in iron status after 14 weeks of cracker consumption through quantification of hemoglobin (Hb), inflammation-adjusted serum ferritin, and soluble transferrin receptor (sTfR).
Child (male, female, intersex, non-binary), aged 9 to 13 years old who attends one of the selected schools
Caregiver or legal guardian is willing to provide informed consent
Child is willing to provide informed assent
Child age is outside the preferred age range (9 to 13 years)
Not enrolled in the participating schools
Unable or unwilling to comply with the study requirements
Illness requiring medical treatment, malaria, severe anemia (hemoglobin (Hb) concentration below 8.0 g/dL as indicated by HemoCue 201+ system), severe acute malnutrition, fever, diarrhea, etc.
Cornell University
Lead sponsor
PATH
Collaborator
Institut Pasteur de Madagascar
Collaborator
Université d'Antananarivo
Collaborator