HEALTHYNSECT: Healthynsect Child Growth and Health Intervention Study

Sponsor

University of Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT06002620

Collaborator

Masinde Muliro University of Science and Technology (Other), Jomo Kenyatta University of Agriculture and Technology (Other)

280

Enrollment

Location

Arms

10.3

Anticipated Duration (Months)

27.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nutrition Status	Dietary Supplement: CSB+ Dietary Supplement: Enriched nutrition food (CEF) Behavioral: Nutrition education Combination Product: Combined nutrition and education	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

The study has four study 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 reminderThe study has four study 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

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Stratified by sex, randomization was done by a team not participating in the study implementation and the randomization scheme sent directly to the assigned distribution staff The products under investigation are packed in similar containers differentiated by a code number only known to the distribution staff who is equally blinded of the products contents.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Mar 9, 2023

Anticipated Primary Completion Date :

Jan 16, 2024

Anticipated Study Completion Date :

Jan 16, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control arm (CA) A positive control group using an existing nutritional intervention with the known effect will be adopted, so as to meet ethical practice and be able to determine the effect of our new intervention response on the experimental group. The study will use double blinded approach with the control group receiving standard known flour of the supercereal CSB+ adjusted for ages as follows:6-8 months infants receiving 31g daily,9-11 months receiving 47g and 12-24 months receiving 86g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.	Dietary Supplement: CSB+ standard care Other Names: Standard care
Experimental: Enriched nutrition arm (ENA) The study will use a Cricket Enriched flour(CEF) - with 20% cricket (, maize, millet, mineral and vitamin premix with amounts served adjusted to ages as:6-8 months infants receiving 29g daily,9-11 months receiving 44g and 12-24 months receiving 80g to supply 200,300 and 550KCal daily respectively, with both the caregiver and person administering the food will be blinded from the content of the flour.	Dietary Supplement: Enriched nutrition food (CEF) enriched cricket flour at 20%
Experimental: Nutrition education arm (NEdA) Combines the control and nutrition education where nutrition education comprises of a video, face to face session and SMS reminder in predetermined regular sessions	Dietary Supplement: CSB+ standard care Other Names: Standard care Behavioral: Nutrition education regular videos, sms reminders and face to face interaction
Experimental: Combined Nutrition Education and enriched nutrition (CEdNA) Combines the Cricket Enriched flour(CEF) and Nutrition education	Dietary Supplement: Enriched nutrition food (CEF) enriched cricket flour at 20% Combination Product: Combined nutrition and education combined enriched cricket flour and nutrition education

Outcome Measures

Primary Outcome Measures

Stunting (Height/Length for age Z scores) [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 Outcome Measures

Gut health [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
Dietary intake [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 7 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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