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

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

Interventions

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.

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.

Sponsors & Collaborators

• PATH

  collaborator OTHER

• Institut Pasteur de Madagascar

  collaborator OTHER

• Université d'Antananarivo

  collaborator UNKNOWN

• Cornell University

  lead OTHER

Principal Investigators

• John Hoddinott, DPhil · Cornell University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

9 Years

Max Age

13 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-28

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Madagascar

Study Locations