CompletedNCT07439185ClinicalTrials.gov record

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

Gut -Microbiota · Inflamation · Iron Absorption

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 9 years - 13 years
Sex eligible: All sexes
Healthy volunteers: Accepted
Participants: 482 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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).

Read the full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Random assignment
Masking: Triple masked

Treatment

Consumption of insect-fortified (crickets and black soldier fly larvae) crackers.

Dietary Supplement: Cricket and Black Soldier Fly Larvae-fortified Cracker

Control

Consumption of rice and corn crackers

Dietary Supplement: Rice and Corn Cracker

Cricket and Black Soldier Fly Larvae-fortified Cracker DIETARY_SUPPLEMENT

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.

Rice and Corn Cracker DIETARY_SUPPLEMENT

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