Clinical trial NCT06002620: Healthynsect Child Growth and Health Intervention Study
Official title: Effect of Cricket Enriched Porridge and Nutrition Education on Stunting, Gut Health and Breastmilk Intake of Infants and Young Children in Western Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Status
Keywords: cricket
insect
complementary feeding
gut health
breastmilk intake
13C sucrose breath test
deuterium oxide
stable isotopes
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Masinde Muliro University of Science and Technology
name: Jomo Kenyatta University of Agriculture and Technology
First posted: 2023-08-21
Enrollment: 284
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The study has four arms namely: Control arm (CA), Enriched nutrition arm (ENA), Nutrition education arm (NEdA) and a Combined Nutrition Education and enriched nutrition (CEdNA).

Cricket Enriched flour(CEF) - with cricket, maize, millet, mineral and vitamin premix Corn-Soy Blend plus(CSB+) - with mineral and vitamin premix Nutrition Education- with video, face to face session and SMS reminder
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Stunting (Height/Length for age Z scores)
timeFrame: 8 months
Secondary outcomes:
measure: Gut health
timeFrame: Baseline
measure: Dietary intake
timeFrame: Baseline for breast milk intake, monthly for 8 months for the rest of the dietary intake information
Other outcomes:
Locations:
city: Siaya
country: Kenya
facility: Rwambwa Sub County Hospital
state: Western
Study officials:
affiliation: Masinde Muliro University of Science and Technology
name: Silvenus O. Konyole, PhD
role: PRINCIPAL_INVESTIGATOR
References: