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

NCT07439185 | Not Yet Recruiting

• 1 other identifier: IRB0149913
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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).

Conditions

Gut -Microbiota; Inflamation; Iron Absorption

Outcome Measures

Primary Outcomes (10)

• 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.

Study Arms (2)

Treatment

EXPERIMENTAL

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

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

Control

PLACEBO COMPARATOR

Consumption of rice and corn crackers

Dietary Supplement: Rice and Corn Cracker

Interventions

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.

Also known as: Treatment Cracker

Treatment

Rice and Corn 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.

Also known as: Control Cracker

Control

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Caregiver does not consent to participate

Sponsors & Collaborators

• Cornell University: lead
• PATH: collaborator
• Institut Pasteur de Madagascar: collaborator
• Université d'Antananarivo: collaborator

Study Sites (1)

FSRP Sschools

Antsirabe, Vakinankaratra Region, Madagascar

Location

Study Officials

• John Hoddinott, DPhil

  Cornell University

  STUDY CHAIR

Central Study Contacts

John Hoddinott, DPhil

CONTACT

240-447-0918; jfh246@cornell.edu

Megan Parker, PhD

CONTACT

202-460-6239; mparker@path.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 27, 2026
• Study Start: February 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: July 2026 to July 2027

Locations

MA (1)