Gut -Microbiota, Inflamation, Iron Absorption
Conditions
Brief summary
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).
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.
Interventions
DIETARY_SUPPLEMENTCricket 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.
DIETARY_SUPPLEMENTRice 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.
Sponsors
Cornell University
PATH
Institut Pasteur de Madagascar
Université d'Antananarivo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to 13 Years
Healthy volunteers
Yes
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut mircrobiome | From enrollment to the end of treatment after 14 weeks of cracker consumption. | 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. |
| Iron via soluble transferrin receptor | From enrollment to the end of treatment after 14 weeks of cracker consumption. | The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through soluble transferrin receptor (mg/L). |
| Intestinal inflammation via calprotectin | From enrollment to the end of treatment after 14 weeks of cracker consumption. | 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). |
| Intestinal inflammation via lactoferrin | From enrollment to the end of treatment after 14 weeks of cracker consumption. | 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). |
| Intestinal inflammation via lipocalin | From enrollment to the end of treatment after 14 weeks of cracker consumption. | 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). |
| Intestinal inflammation via anlpha-1 antitrypsin | From enrollment to the end of treatment after 14 weeks of cracker consumption. | 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). |
| Intestinal inflammation via myeloperoxidase | From enrollment to the end of treatment after 14 weeks of cracker consumption. | 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). |
| Systemic inflammation via quantification of circulating cytokines | From enrollment to the end of treatment after 14 weeks of cracker consumption. | 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. |
| Iron via quantification of hemoglobin | From enrollment to the end of treatment after 14 weeks of cracker consumption. | The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through quantification of hemoglobin (g/dL). |
| Iron via inflammation adjusted ferritin | From enrollment to the end of treatment after 14 weeks of cracker consumption. | The investigators will assess iron status at baseline (0 weeks) and endline (14 weeks) through inflammation adjusted ferritin (µg/L). |
Countries
Madagascar
Contacts
CONTACTJohn Hoddinott, DPhil
CONTACTMegan Parker, PhD
STUDY_CHAIRJohn Hoddinott, DPhil
Cornell University
Outcome results
None listed