Plain English Summary
Background and study aims
In Kenya children aged from six months to five years are usually given porridge in between meals and this usually continues when the children join nursery school. Protein and mineral deficiency is common in Kenyan children and insects have been shown to contain sufficient proteins and minerals when supplemented in complementary food. Cricket rearing is new in Kenya and farmed crickets could be used to improve the nutritional status and gut health of schoolchildren in Kenya. The aim of this study is to assess the acceptance and impact on nutrition of a daily school meal of a cricket-based porridge, to provide information on cricket as an alternative animal protein source which may be cheaper and affordable to many Kenyans and therefore help curb child malnutrition.
Who can participate?
Children aged 3-7 attending Cheptigit nursery school
What does the study involve?
Participating children are given a daily portion of porridge from Monday to Friday for 6 months. The children are randomly allocated to receive either cricket-based porridge, milk-based porridge, or plant-based porridge. The children are assessed for their acceptance of the food with questionnaires. Their height, weight, skinfolds, and mid upper arm circumference are measured. They also provide finger prick blood samples and stool samples.
What are the possible benefits and risks of participating?
Children participating in this study may benefit from the daily porridge and the monthly health checks. They may feel a little pain during the finger prick. There are no other anticipated risks in this study.
Where is the study run from?
Cheptigit nursery school (Kenya)
When is the study starting and how long is it expected to run for?
February 2017 to August 2017
Who is funding the study?
The Consultative Research Committee for Development Research (FFU), Danida, Ministry of Foreign Affairs (Denmark)
Who is the main contact?
1. Dr Nanna Roos (scientific)
nro@nexs.ku.dk
2. Dr John Kinyuru (scientific)
jkinyuru@agr.jkuat.ac.ke
3. Miss Carolyne Kipkoech (public)
kipkoechcarolyne@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nanna Roos
ORCID ID
http://orcid.org/0000-0002-9733-9523
Contact details
University of Copenhagen
Department of Nutrition
Exercise and Sports (NEXS)
Rolighedsvej 26
Frederiksberg
1958
Denmark
+45 (0)3532 2497
nro@nexs.ku.dk
Type
Scientific
Additional contact
Dr John Kinyuru
ORCID ID
Contact details
Jomo Kenyatta University of Agriculture and Technology
Department of Food Science and Technology
PO Box 62000
Nairobi
00200
Kenya
+254 (0)723 667 432
jkinyuru@agr.jkuat.ac.ke
Type
Public
Additional contact
Miss Carolyne Kipkoech
ORCID ID
Contact details
Jomo Kenyatta University of Agriculture and Technology
Department of Food Science and Technology
PO Box 62000-002000
Nairobi
00200
Kenya
+254 (0)721 481 324
kipkoechcarolyne@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MKU/ERC/0274
Study information
Scientific title
The impact of edible cricket in a school meal programme on nutritional status, gut microbiota and health in pre-school children (age 3-4 years): an individually randomized, single-blinded controlled trial in Uasin Gishu County, Kenya
Acronym
CRICKFOOD
Study hypothesis
School meal serving with a fortified porridge made with edible insect (cricket) supports growth (linear and weight) at least equal to a positive control group receiving a fortified porridge with milk powder, and better than a negative control of a fully plant based fortified porridge.
Ethics approval
Mount Kenya University Ethical Review Committee, 09/01/2017, ref: MKU/ERC/0274
Study design
Individually randomized single-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
No participant information sheet available. Parents received oral information and signed a consent form
Condition
Nutrition
Intervention
The intervention will involve feeding children in a school setup. The children in the pre primary section will be given porridge every five days in a week. Treatment is a daily food supplement served as a school meal. Children will be randomly allocated (simple randomization) to be given 65 grams of either milk based, cricket based or cereal based flour in form of porridge:
1. Intervention: a fortified porridge with edible insects (cricket)
2. Positive control: a similarly fortified porridge with milk powder
3. Negative control: a fortified plant-based porridge
The food groups are blinded for investigators, while food group cannot be blinded to participants due to different appearance and taste. Children will be served porridge every day from Monday to Friday while at school for a period of six months. The children will line up for porridge depending on their trial arm and then they will be served and observed as they take the porridge and any remaining volume recorded.
There will be baseline measures and dietary intake questionnaires at the beginning and at the end of the trial, with baseline and end line measures of stool, hemoglobin through finger prick, fatty acid analysis, weight, height, and mid upper arm circumference. Every month the children will undergo morbidity checks, weight, height, and mid upper arm circumference measures.
Intervention type
Supplement
Phase
Drug names
Primary outcome measures
Weight for Height (Z score), measured using Seca digital weight measuring scale at 1,2, 3, 4, 5 and 6 months
Secondary outcome measures
1. Porridge acceptability, measured daily using amount of porridge consumed assessed by weighing any remaining quantity of the porridge at the end of the meal
2. School attendance, measured daily using school registration of each child
3. Stool microbiota, analysed using a stool sample at baseline and endline (6 months)
4. EED (Environmental Enteric Dysfunction) prevalence, measured using a stool sample (indicators to be assessed: myeloperoxidase and neopterin) at baseline and endline (6 months)
Overall trial start date
14/02/2017
Overall trial end date
14/08/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Children attending Cheptigit nursery school
2. Weight for Height (WHZ) – ≥-3 Z scores
3. Caregivers who will accept that their children participate in the study and sign the consent form
4. Children who are willing to take porridge and follow the study procedure and therefore assent to the study procedure
5. Age 3-7 years
Participant type
Healthy volunteer
Age group
Child
Gender
Both
Target number of participants
135
Participant exclusion criteria
1. Weight for Height (WHZ) ≤ 3 Z scores
2. Children allergic to any ingredients in the porridge
3. Children whose parents do not consent to the study
4. Children with obvious signs of disease
Recruitment start date
10/03/2017
Recruitment end date
30/03/2017
Locations
Countries of recruitment
Kenya
Trial participating centre
Cheptigit nursery school
00200
Kenya
Sponsor information
Organisation
University of Copenhagen
Sponsor details
Department of Nutrition
Exercise and Sports
Rolighedsvej 26
Frederiksberg
1958
Denmark
+45 (0)3532 2497
nro@nexs.ku.dk
Sponsor type
University/education
Website
Organisation
Jomo Kenyatta University of Agriculture and Technology
Sponsor details
Department of Food Science and Technology
PO Box 62000
Nairobi
00200
Kenya
+254 (0)67 587 0001
info@jkuat.ac.ke
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The Consultative Research Committee for Development Research (FFU), Danida, Ministry of Foreign Affairs, Denmark. Funded under the grant for the project 'GREEiNSECT - insects for green economy' (www.greeinsect.ku.dk)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal, to be submitted November 2017
IPD sharing plans
This study is collaborative research between John Kinyuru, Jomo Kenyetta University of Agriculture and Tecnology (JKUAT), Nairobi, Kenya (jkinyuru@agr.jkuat.ac.ke) and Nanna Roos, University of Copenhagen, Denmark (nro@nexs.ku.dk). Request for access to dataset should be sent jointly to these collaborating partners.
Intention to publish date
01/11/2017
Participant level data
Available on request
Results - basic reporting
Publication summary