An interventional study of Cricket and Black Soldier Fly Larvae-fortified Cracker and Rice and Corn Cracker in Gut -Microbiota, Inflamation and Iron Absorption, sponsored by Cornell University. Completed at 1 site in Madagascar. Open to participants aged 9 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Cornell University · Not applicable, Interventional, and Basic science
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).
Food insecurity, child malnutrition, and anemia remain significant public health problems globally, including in Madagascar where 40% of children under 5 years of age are chronically malnourished (stunted), 8% are wasted, and 46% are anemic (DHS, 2021). Interventions aimed at addressing this have often foundered on the fact that the foods that would address these nutrient deficiencies are physically unavailable, too expensive for poor households to purchase, or contribute to climate change or environmental degradation. Consequently, there is interest in the development of novel food products that could contribute to reducing malnutrition in all its forms, without the drawbacks of relying on existing food products. One possibility is to develop food products based on insects. Edible insects are low-cost, climate friendly, with nutritional profiles akin to meat. They contain high amounts of protein, iron, and zinc while also providing a novel source of prebiotic fiber. It is hypothesized that insect-based foods could improve children's health outcomes as measured by gut inflammation, anemia, and growth. The investigators and others have developed an insect-fortified cracker snack, suitable for the nutritional requirements of school-age children living in Southeast Madagascar. The investigators have already assessed the product's nutrient profile. They also have documented the safety tests done to date; these show that the snack is safe for human consumption. The test results have been submitted to the Malagasy regulatory authority for registering food and health products and the government has approved the insect powders as food for human consumption and issued "Certificates for Human Consumption". The investigators have also conducted an acceptability trial that showed that child participants like the organoleptic characteristics of the crackers and regularly consume the crackers in biologically meaningful quantities.
Cornell University is the lead sponsor of 103 studies on the registry; 16 are open to participants now.
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Inclusion criteria for children
Exclusion criteria for children
Inclusion criteria for parents • Willing to participate in completing surveys about demographics and household dynamics (assets, housing structure, etc.)
Exclusion criteria for parents
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Consumption of insect-fortified (crickets and black soldier fly larvae) crackers.
Dietary Supplement: Cricket and Black Soldier Fly Larvae-fortified Cracker
Consumption of rice and corn crackers
Dietary Supplement: Rice and Corn Cracker
Children will receive a sachet containing 50g of insect crackers. 50 grams was chosen as the amount because the investigators know, from their earlier acceptability trial, that children are willing to consume this amount (in the acceptability trial, approximately 80% of children consumed 80% or more of the 50g of crackers that they were provided). Crackers will be provided Monday-Friday for approximately 14 weeks.
Also known as: Treatment Cracker
Children will receive a sachet containing 50g of insect crackers. 50 grams was chosen as the amount because the investigators know, from their earlier acceptability trial, that children are willing to consume this amount (in the acceptability trial, approximately 80% of children consumed 80% or more of the 50g of crackers that they were provided). Crackers will be provided Monday-Friday for approximately 14 weeks.
Also known as: Control Cracker
Gut mircrobiome
The investigators will assess gut microbiome composition at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through 16S rRNA sequencing and quantification of fecal biomarkers.
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Iron via soluble transferrin receptor
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through soluble transferrin receptor (mg/L).
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via calprotectin
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: calprotectin (µg/g).
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via lactoferrin
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: lactoferrin (µg/g).
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via lipocalin
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: lipocalin (ng/g).
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via anlpha-1 antitrypsin
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: anlpha-1 antitrypsin (mg/g).
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Intestinal inflammation via myeloperoxidase
The investigators will assess intestinal inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through the quantification of following fecal marker: myeloperoxidase (µg/g).
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Systemic inflammation via quantification of circulating cytokines
The investigators will also assess systemic inflammation at baseline (0 weeks), midline (6 weeks), and endline (14 weeks) through quantification of circulating cytokines, including IL-1β, IL-2, IL-4, IL-6, IL-10, IL-22, TNF-α, IFN-γ, CCL2, all expressed as pg/mL.
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Iron via quantification of hemoglobin
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through quantification of hemoglobin (g/dL).
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Iron via inflammation adjusted ferritin
The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through inflammation adjusted ferritin (µg/L).
Time frame: From enrollment to the end of treatment after 14 weeks of cracker consumption.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: July 2026 to July 2027
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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