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Completed

NCT Number: NCT06002620

Healthynsect Child Growth and Health Intervention Study

Malnutrition in all its forms is still a problem in resource limited settings including Kenya driven by low diet quality, food preparation and feeding practices including hygiene. Edible insects are currently of interest in alleviating malnutrition due to their energy density, high protein, vitamins and micronutrients (iron, zinc). Among the insects of preference are the crickets which have been shown to encourage the growth of probiotics (Bifidobacterium animalis) which support gut health increasing nutrient absorption and reduces systemic inflammation. Despite the nutritional value of insects and the contribution of cricket to improved gut health, there is limited evidence on the benefit of cricket based complementary food in the reduction of stunting amongst infants and young children. This study aim to determine the effect of integrating two nutrition interventions (cricket enriched porridge with nutrition education) on the infant and young child growth (stunting) and gut health in Alego Usonga Sub-County in Siaya County of rural western part of Kenya.

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Key information

Conditions

Age range

6 month–7 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rwambwa Sub County Hospital

Siaya, Western, 40600, Kenya

About this study

Malnutrition in all its forms is still prevalent in resource limited settings driven by low diet quality, food preparation and feeding practices including hygiene. Untreated early childhood malnutrition deprives the child from living to full potential, by increasing susceptibility to childhood infections and is life threatening. Insects are currently of interest in alleviating malnutrition due to their energy density, high protein, vitamins and micronutrients (iron, zinc). Crickets positively support growth of probiotics (Bifidobacterium animalis) which support gut health increasing nutrient absorption and reduces systemic inflammation. Single nutrition interventions are confirmed to be less effective in reducing malnutrition and stunting in particular, with a combination of nutrition-specific and nutrition-sensitive interventions yielding better outcome. In spite of recognizing nutritional value of insects and the contribution of cricket to improved gut health, there is limited evidence on the benefit of cricket based complementary food in reducing stunting amongst infants and young children. This study aims to determine the effect of integrating two nutrition interventions (cricket enriched porridge with nutrition education) on the infant and young child growth (stunting status) and gut health in rural Kenya; Alego Usonga Sub-County in Siaya County. The study is based on a 2x2 factorial design among infants aged 6 months and target to assess the main and combined effect of the two interventions (nutrition education and cricket enriched porridge) on the infant and young child's stunting and gut health. The study has four arms namely: Control arm (CA) where the study participants receive the standard care comprising of the supercereal Corn Soy Blend Plus (CSB+) in amounts adjusted for age, Enriched nutrition arm (ENA) where they receive the improved complementary food enriched with cricket and optimized for all the benefits of the cricket in amounts adjusted for age, Nutrition education arm (NEdA) where they receive nutrition education and a Combined Nutrition Education and enriched nutrition (CEdNA). The required sample size (based on the following parameters: Number of groups: = 4, effect size = 0.2, significance level = 0.05, power of test = 80%) is 70 study participants per study arm yielding a total of 280.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 6 months at the time of enrolment,
  • Hemoglobin (Hb) of ≥7 g/dl (not severely anemic) and
  • Height for Age (HAZ) ≥-3 Z scores (not severely stunted).

Exclusion criteria

  • Those obviously ill and need medical attention who are referred for care as per ministry of health protocol
  • Children strictly fed on formula feed with no breast feeding
  • Infants whose caregivers do not consent or don't commit to adhere to the feeding regimen prescribed

Treatment and study plan

CSB+

Dietary Supplement

standard care

Other names: Standard care

Enriched nutrition food (CEF)

Dietary Supplement

enriched cricket flour at 20%

Nutrition Education

Behavioral

regular videos, sms reminders and face to face interaction

Combined nutrition and education

Combination Product

combined enriched cricket flour and nutrition education

Primary outcomes

  1. Stunting (Height/Length for age Z scores)

    Time frame: 8 months

    Children who are too short for their age according to WHO 2005 growth standards. Length/Height in cm and age in months will be converted to Z scores using WHO Anthro and the values used to categorize growth as per the WHO 2005 standards

Secondary outcomes

  1. Gut health

    Time frame: Baseline

    the integrity of the gut measured from stool illustrated by the gut microbiota(microbiome),Myeloperoxidase enzyme levels(MPO) as indicator of tissue inflammation plus butyrate concentration, alpha-1-anti trypsin (ATT) and Neopterin (NEO) & and 13C stable isotope breath test measured by the time it takes to recover 50% of the stable isotope and also the amount of carbon dioxide produced in the first 90 minutes after the dose with the 13Carbon stable isotope

  2. Dietary intake

    Time frame: Baseline for breast milk intake, monthly for 8 months for the rest of the dietary intake information

    Total dietary intake including breast milk intake measured by deuterium oxide technique

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Jomo Kenyatta University of Agriculture and Technology
  • Masinde Muliro University of Science and Technology

Registry information

Official study title

Effect of Cricket Enriched Porridge and Nutrition Education on Stunting, Gut Health and Breastmilk Intake of Infants and Young Children in Western Kenya

Acronym: HEALTHYNSECT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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