Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron Status in Malagasy Schoolchildren
Starting soon · Not applicable
Conditions studied: Gut -Microbiota, Inflamation, Iron Absorption
In brief
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).
Key facts
- Study ID
- NCT07439185
- Run by
- Cornell University
- People needed
- 650
- Starts
- 2026-02-01
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2026-02-27
Who can join
Age: 9 and older, up to 13. Sex: any. Healthy volunteers: accepted.
Where it is running
- FSRP Sschools — Antsirabe, Vakinankaratra Region, Madagascar
Full record on ClinicalTrials.gov
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