Healthynsect Child Growth and Health Intervention Study

Nutrition Status Clinical Trial

— HEALTHYNSECT  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002620
• Other study ID #: WP2 HEALTHYNSECT
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2023
• Est. completion date: January 16, 2024

Study information

• Verified date: August 2023
• Source: University of Copenhagen
• Contact: Nanna Roos, PhD
• Phone: +4535332497
• Email: nro[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: January 16, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 7 Months

Eligibility

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

Related Conditions & MeSH terms

• Nutrition Status

Intervention

Dietary Supplement:
• CSB+
standard care
• Enriched nutrition food (CEF)
enriched cricket flour at 20%

Behavioral:
• Nutrition education
regular videos, sms reminders and face to face interaction

Combination Product:
• Combined nutrition and education
combined enriched cricket flour and nutrition education

Locations

Country	Name	City	State
Kenya	Rwambwa Sub County Hospital	Siaya	Western

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Jomo Kenyatta University of Agriculture and Technology, Masinde Muliro University of Science and Technology

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stunting (Height/Length for age Z scores)	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	8 months
Secondary	Gut health	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	Baseline
Secondary	Dietary intake	Total dietary intake including breast milk intake measured by deuterium oxide technique	Baseline for breast milk intake, monthly for 8 months for the rest of the dietary intake information