Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002620
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-07-10
Brief Title:
Healthynsect Child Growth and Health Intervention Study
Sponsor:
University of Copenhagen
Organization:
University of Copenhagen
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEALTHYNSECT
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 childs 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 02 significance level 005 power of test 80 is 70 study participants per study arm yielding a total of 280
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None