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

Обзор

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).

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка 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.

Первичные конечные точки

• Gut mircrobiome [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Iron via soluble transferrin receptor [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Intestinal inflammation via calprotectin [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Intestinal inflammation via lactoferrin [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Intestinal inflammation via lipocalin [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Intestinal inflammation via anlpha-1 antitrypsin [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Intestinal inflammation via myeloperoxidase [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Systemic inflammation via quantification of circulating cytokines [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Iron via quantification of hemoglobin [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]
• Iron via inflammation adjusted ferritin [Срок оценки: From enrollment to the end of treatment after 14 weeks of cracker consumption.]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Madagascar · 1 центр

• FSRP Sschools — Antsirabe

Идентификаторы

NCT: NCT07439185 · IRB0149913

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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