Impact of a Cricket and Black Soldier Fly Larvae-Fortified Cracker on the Gut Microbiome and Iron Status in Malagasy Schoolchildren

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Absorption; Gut -Microbiota; Inflamation
• Intervention / Treatment: Dietary supplement: Cricket and Black Soldier Fly Larvae-fortified Cracker; Dietary supplement: Rice and Corn Cracker

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 650
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Hoddinott, DPhil; Phone Number: 240-447-0918; Email: jfh246@cornell.edu
• Study Contact Backup: Name: Megan Parker, PhD; Phone Number: 202-460-6239; Email: mparker@path.org

Study Locations

• Madagascar
  • Vakinankaratra Region
    • Antsirabe, Vakinankaratra Region, Madagascar
      • FSRP Sschools
      • Contact: Megan Parker, PhD; Phone Number: 202-460-6239; Email: mparker@path.org
      • Contact: John Hoddinott, PhD; Phone Number: 240-447-0918; Email: jfh246@cornell.edu
      • Principal Investigator: John Hoddinott, DPhil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria for children

• 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

Exclusion criteria for children

• 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.
• Covid-exposure or symptoms: loss of smell or taste
• History of food allergies or adverse reactions to any edible insects
• Chronic severe medical condition or congenital anomalies requiring frequent medical attention or interfering with dietary consumption
• Caregiver does not give consent, or child does not assent

Inclusion criteria for parents • Willing to participate in completing surveys about demographics and household dynamics (assets, housing structure, etc.)

Exclusion criteria for parents

• Caregiver does not consent to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Consumption of insect-fortified (crickets and black soldier fly larvae) crackers.	Dietary supplement: Cricket and Black Soldier Fly Larvae-fortified 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.; Other Names: Treatment Cracker
Placebo Comparator: Control; 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.; Other Names: Control Cracker

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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).	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).	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).	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).	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.	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).	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).	From enrollment to the end of treatment after 14 weeks of cracker consumption.

Collaborators and Investigators

• Sponsor: Cornell University
• Collaborators: PATH; Institut Pasteur de Madagascar; Université d'Antananarivo
• Investigators: Study Chair: John Hoddinott, DPhil, Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB0149913

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: July 2026 to July 2027
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No